View Future Growthgenedrive 過去の業績過去 基準チェック /06genedriveは1%の年平均成長率で業績を伸ばしているが、Life Sciences業界はgrowingで4.9%毎年増加している。売上は成長しており、年平均19.3%の割合である。主要情報1.04%収益成長率47.41%EPS成長率Life Sciences 業界の成長26.83%収益成長率19.27%株主資本利益率n/aネット・マージン-455.11%前回の決算情報31 Dec 2025最近の業績更新お知らせ • Dec 03genedrive plc to Report Fiscal Year 2025 Results on Dec 05, 2025genedrive plc announced that they will report fiscal year 2025 results at 8:00 AM, GMT Standard Time on Dec 05, 2025お知らせ • Nov 22genedrive plc to Report Fiscal Year 2024 Results on Nov 29, 2024genedrive plc announced that they will report fiscal year 2024 results at 8:00 AM, GMT Standard Time on Nov 29, 2024お知らせ • Mar 16genedrive plc to Report First Half, 2024 Results on Mar 28, 2024genedrive plc announced that they will report first half, 2024 results on Mar 28, 2024Reported Earnings • Dec 01Full year 2023 earnings released: UK£0.055 loss per share (vs UK£0.055 loss in FY 2022)Full year 2023 results: UK£0.055 loss per share (in line with FY 2022). Net loss: UK£5.15m (loss widened 10% from FY 2022).お知らせ • Nov 17genedrive plc to Report Fiscal Year 2023 Results on Nov 30, 2023genedrive plc announced that they will report fiscal year 2023 results on Nov 30, 2023Reported Earnings • Nov 22Full year 2022 earnings released: UK£0.055 loss per share (vs UK£0.012 loss in FY 2021)Full year 2022 results: UK£0.055 loss per share (further deteriorated from UK£0.012 loss in FY 2021). Net loss: UK£4.68m (loss widened UK£3.98m from FY 2021).すべての更新を表示Recent updatesお知らせ • May 06Genedrive Plc Transitions MT-RNR1 Test To Business As Usual Clinical ServiceGenedrive plc announced that, from 1 May 2026, University Hospitals Sussex NHS Foundation Trust hospitals transitioned to Business as Usual routine clinical service of the Genedrive MT-RNR1 ID kit for the prevention of Antibiotic Induced Hearing Loss in neonates admitted to Neonatal Intensive Care Units. UHS Royal County Sussex Hospital's Trevor Mann Baby Unit provides specialist care for approximately 400 NICU admissions annually and has been a participating site in the PALOH-UK programme, which aims to address National Institute for Clinical Care and Excellence Real World Evidence generation requirements. To date, nearly 40 babies in NICUs have been identified with the MT-RNR1 variant since introduction of the test in the UK, enabling alternative antibiotic prescription and reducing the risk of aminoglycoside-induced lifelong hearing loss. Funding for PALOH-UK sites is provided by the Office for Life Sciences and National Institute for Health and Care Research and will cease by June 2026, with some sites completing earlier. Subsequent review and issuance of final guidance by NICE is expected around July 2027. Genedrive has two CE-IVD approved and NICE-recommended tests in NHS clinical use. The Genedrive CYP2C19 ID Kit identifies stroke patients who will not respond to the current standard of care, Clopidogrel, used to reduce risk of secondary stroke. The Genedrive MT-RNR1 ID Kit helps prevent antibiotic-induced hearing loss in newborns, enabling treatment decisions within actionable timeframes at the point of care.お知らせ • Apr 23Genedrive plc Announces Nhs England Commercial Strategy for Rapid Mt-Rnr1 TestingGenedrive plc (AIM: GDR), the point of care pharmacogenetic testing company, welcomed publication from NHS England of a Preliminary market engagement notice under the Procurement Act 2023, to inform the NHS commercial strategy for rapid genetic MT-RNR1 testing in neonates to prevent antibiotic induced hearing loss. To date, since introduction, the rapid MT-RNR1 test has been used as part of routine clinical practice by approximately 900 neonatal nurses for over 10,000 babies admitted to NICUs, enabling more than 30 to avoid lifelong hearing loss as a result of aminoglycoside antibiotic exposure. In the UK, Genedrive® MT-RNR1 ID kit is being implemented and used in the Neonatal Intensive Care Units ("NICU") of 14 hospitals across the four UK nations as part of a real world evidence generation programme (PALOH-UK) funded by the National Institute for Health and Care Research (NIHR) and the UK Government Office for Life Sciences (OLS). The test also has conditional recommendation for use in the NHS by the National Institute for Health and Care Excellence ("NICE") whilst further real world evidence is generated. Genedrive estimates that annual NICU admissions in these NICUs represent approximately 10% of admissions in the UK. Additionally, since October 2025, implementation of the Genedrive® MT-RNR1 ID kit into all NHS Scotland Health boards has been actively progressing under a phased implantation programme with the Accelerated National Innovation Adoption (ANIA) pathway led by the Scottish Centre for Sustainable Delivery. The PALOH-UK programme is scheduled to complete by July 2026, with subsequent NICE review and issuance of final guidance communicated to be approximately July 2027. Post PALOH-UK and ahead of final guidance, business case progression will continue as planned to enable PALOH-UK sites to rapidly transition to Business as Usual use. In addition to anticipated timelines, the premarket engagement notes anticipate a publication date of tender notice of 1 January 2027 and go-live target date of 1 July 2027, subject to NICE guidance outcome.お知らせ • Mar 09genedrive plc has completed a Follow-on Equity Offering in the amount of £0.909643 million.genedrive plc has completed a Follow-on Equity Offering in the amount of £0.909643 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 90,964,264 Price\Range: £0.01 Transaction Features: Rights Offeringお知らせ • Feb 14+ 2 more updatesgenedrive plc has completed a Follow-on Equity Offering in the amount of £0.5 million.genedrive plc has completed a Follow-on Equity Offering in the amount of £0.5 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 50,000,000 Price\Range: £0.01 Transaction Features: Subsequent Direct Listingお知らせ • Dec 09genedrive plc, Annual General Meeting, Dec 31, 2025genedrive plc, Annual General Meeting, Dec 31, 2025. Location: 46 grafton street, m13 9xx, manchester United Kingdomお知らせ • Dec 03genedrive plc to Report Fiscal Year 2025 Results on Dec 05, 2025genedrive plc announced that they will report fiscal year 2025 results at 8:00 AM, GMT Standard Time on Dec 05, 2025お知らせ • Dec 02genedrive plc Announces Pilot Programme Study Results Underpinning Nhs Implementation Guide for Cyp2c19 Genotype Testing Presented At the Uk Stroke Forumgenedrive plc notes the presentation of two posters by authors from NHS England ("NHSE") Network of Excellence in Pharmacogenomics, the NHSE Genomics Unit, NHSE National Stroke Programme, and Manchester Centre for Genomic Medicine at the UK Stroke Forum, Aberdeen, 25-27 November 2025. Data presented in these posters underpinned the recently published "NHS implementation guide for CYP2C19 genotype testing to guide Clopidogrel use after ischaemic stroke or transient ischaemic attack ("TIA") to support prescribing decisions in stroke. As outlined in the online presentation (Personalising Medicines with Genomics), the National Pilot Programme was conducted at four geographically diverse NHS stroke units across England. The results included laboratory CYP2C19 testing assessed at Doncaster, St. George's and Exeter (December 2024 - April 2025), and Point-of Care ("PoC") rapid CYP2C19 genetic testing assessed using the Genedrive®? CYP2C19 ID kit at Salford Royal Hospital's Hyper Acute Stroke Centre (March 2025 - April 2025). Key findings and conclusions from these were; A higher prevalence of patients unlikely to respond to clopidogrel identified in the near-patient arm (33%) versus the laboratory arm (29%)." The Company estimates that an additional c. 4,200 stroke patients benefitting from alternative prescribing decisions could be identified annually using the Genedrive CYP2C19 ID Kit due to its increased target coverage and ethnic inclusivity. Test results impacted prescription practices, guiding prescription changes and aligning treatment with patients' genetic profiles for better outcomes. Notably, 100% of patients in the genedrive PoC arm requiring clopidogrel prescription had their results available whilst on-ward, whereas 88% of patients in the laboratory arm had been discharged (requiring follow-up activities for prescription change activities). Genedrive®? CY P2C19 ID kit "test failure rate of 0.49%, in the acute clinical setting. Implementation of Genedrive®? CYp2C19 testing was feasible, scalable and effective in providing immediate availability of results during acute clinical settings. Moreover, the findings substantiate the clinical utility of CYP2C19 Genotype-guided antiplatelet therapy in the management of patients with ischemic stroke or TIA, particularly with diverse British and European populations. Rapid availability of test results enables actionable prescription choices and reduces the risk of less effective medications being prescribed for secondary prevention of stroke. CYP2C19 interventional testing is estimated to offer PS160M of value annually to the UK NHS, with rapid CYP2C19 testing estimated to release 62,500 bed days and 235,000 healthcare professional hours annually and aligns perfectly with NHS 10-year plan ambitions for realising the patient and financial benefits of shifting spending to prevention from treatment.お知らせ • Nov 27Genedrive plc Announces Nhs Implementation Guide Published for Cyp2c19 Genotype Testinggenedrive plc notes the publication of the "NHS implementation guide for CYP2C19 genotype testing to guide Clopidogrel use after ischaemic stroke ("IS") or transient ischaemic attack ("TIA") to support prescribing decisions in stroke. Following the National Institute for Health and Care Excellence ("NICE") recommendation for CYP2C19 Genotypeing in TIA and IS including the Genedrive®? CYP2C19 ID Kit as the preferred rapid testing platform, and a national pilot implementing both laboratory and "rapid testing" approaches, the implementation guide encourages stroke services to use the guide to plan how CYP2C19 genotyping could be integrated locally. Interim presentation of the pilot results highlighted that the vast majority of stroke patients had moved further down the care pathway by the time results were available from laboratory testing (which takes several days to weeks), whereas actionable results were available from rapid testing within just over one hour. The guide notes that; Patients at hyperacute stroke units typically have a short length of stay, which may be more suitable for rapid testing. In the context of TIA and non-disabling stroke, clopidogrel is typically started immediately. Turnaround time of laboratory testing means patients may require an additional appointment to change their prescription. This group of patients may be receiving less effective secondary prevention for the days between the test and until an alternative medicine is started. Rapid testing may reduce the need for follow-up appointments or additional communication to other services to action a prescribing decision.お知らせ • Nov 26genedrive plc Announces Scotland National Roll-Out of Genedrive MT-RNR1 ID Kitgenedrive plc note the recent media coverage of its Genedrive MT-RNR1 ID Kit, which reduces the risk of deafness in newborn babies and introduced initially by NHS Greater Glasgow and Clyde. The Genedrive MT-R NR1 ID Kit will start being used for babies requiring antibiotic treatment for infections within the Neonatal Intensive Care Unit at the Royal Hospital for Children ("RHC") in Glasgow, with the Royal Alexandra Hospital and Princess Royal Maternity Hospital to follow soon after, as part of a phased rollout to all NHS Scotland Health Boards with neonatal units over the coming months.お知らせ • Sep 25+ 1 more updategenedrive plc has completed a Follow-on Equity Offering in the amount of £3.1975 million.genedrive plc has completed a Follow-on Equity Offering in the amount of £3.1975 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 400,000,000 Price\Range: £0.002 Security Features: Attached Warrants Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 1,198,750,000 Price\Range: £0.002 Security Features: Attached Warrants Transaction Features: Subsequent Direct Listingお知らせ • Sep 24genedrive plc has filed a Follow-on Equity Offering in the amount of £0.3 million.genedrive plc has filed a Follow-on Equity Offering in the amount of £0.3 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 150,000,000 Price\Range: £0.002 Security Features: Attached Warrantsお知らせ • Aug 21genedrive plc Announces the Genedrive MT-RNR1 ID Kit Is Being Introduces by NHS Greater Glasgow and Clydegenedrive plc announced that the Genedrive MT-RNR1 ID Kit, which reduces the risk of deafness in newborn babies is being introduced by NHS Greater Glasgow and Clyde in September 2025 as part of the national rollout funded by the Scottish Government ("Genetic test to prevent hearing loss in newborns to begin national rollout in NHS Greater Glasgow and Clyde - NHSGGC). The Genedrive MT-R NR1 ID Kit will start being used for babies requiring antibiotic treatment for infections within the Neonatal Intensive Care Unit at the Royal Hospital for Children ("RHC") in Glasgow next month, with the Royal Alexandra Hospital and Princess Royal Maternity Hospital to follow soon after. It will be rolled out to all territorial health boards with neonatal units over the next 18 months. The initiative follows an assessment by the Chief Scientist Office funded Accelerated National Innovation Adoption ("ANIA") pathway, led by the Centre for Sustainable Delivery ("CfSD"), and a Programme for Government commitment from the Scottish Government to provide PS0.8 million to support national adoption. It follows the ongoing UK-wide PALOH (Pharmacogenetics to Avoid Loss of Hearing) programme and assessment by the Scottish Health Technologies Group. Scotland's Public Health Minister Jenni Minto visited the RHC neonatal unit to meet clinicians and representatives from the West of Scotland Innovation Hub ("WoSIH"), who have played a leading role in bringing the innovation to Scotland. Ms Minto also discussed the planned national rollout with members of the CfSD and once fully implemented, it is anticipated that more than 3,000 newborn babies would be tested during the first year. Dr Helen McDevitt, Consultant Neonatologist with NHSGGC and clinical lead for the PALOH-UK study at the RHC, said: "The introduction of this point-of-care genetic testing for newborn babies requiring antibiotic treatment for bacterial infection is a landmark moment for neonatal care in Scotland. By introducing this test, the Company is at the forefront of Point of Care pharmacogenetic testing in emergency healthcare. Pharmacogenetics informs on how individual genetics impact a medicines ability to work for you. Therefore, by using pharmacogenetics, medicine choices can be personalised, made safer and more effective. The Company has launched its two products, the Genedrive MT- RHC MT-RNR1 ID kit and the Genedrive CYP2C19 ID Kit, both developed and validated in collaboration with NHS partners and deployed on its point of care thermocycler platform. Both tests are single-use disposable cartridges which are ambient temperature stable, circumventing the requirement for cold chain logistics. The Directors believe the Genedrive MT-MNR1 ID Kit is a worlds-first and allows clinicians to make a decision on antibiotic use in neonatal intensive care units within 26 minutes, ensuring vital care is delivered, avoiding adverse effects potentially otherwise encountered and with no negative impact on the patient care pathway. Its CYP2C19ID Kit is a world-first and allows clinicians to making a decision on antibiotic use in Neonatal intensive care units within 26 days, ensuring vital care is delivered. Its CYP2C 19 ID Kit is delivered, avoiding adverse effects potential otherwise encountered and with no negative impacts on the patient care pathway. its CYP2C19 ID kit is expected to provide PS0.8m to support national adoption.お知らせ • Aug 13Genedrive plc Provides Earnings Guidance for the Year Ending June 30, 2025genedrive plc provided earnings guidance for the year ending June 30, 2025. For the period, the company expects a doubling of total income of circa. £1 million (FY24: £0.5 million), driven by increased sales momentum in half year 2025 which saw income of £0.65 million (Fist half of 2025 £0.35 million). The Company's overheads in 2025 remained in line with the prior year however with a strategic shift towards focussed commercial activities.お知らせ • May 30genedrive CYP2C19 ID Kit Receives CE-Certification Under the European in Vitro Diagnostics Regulationgenedrive plc announced the successful certification of its rapid CYP2C19 ID Kit genotyping platform under the European In Vitro Diagnostic Regulation ("IVDR") 2017/746. The IVDR replaces the In Vitro Diagnostic Directive ("IVDD") and is the current required regulatory basis for placing on the market, making available and putting into service any new In Vitro diagnostic medical devices within the European Union, with CE-IVD certification recognised for facilitating registration in several non-European countries. Approximately 30% of individuals, and up to 56% in certain ethnic groups, carry DNA variants in the CYP2C19 gene which result in sub-optimal activity of the antiplatelet drug Clopidogrel, commonly prescribed in patients with serious cardiovascular events such as Ischaemic Stroke ("IS"), Transient Ischaemic Attack ("TIA") and Acute Coronary Syndrome, where patients with these variants who are prescribed Clopidogrel typically experiencing worse outcomes. The Genedrive® CYP2C19 ID Kit identifies five of these DNA variants, some of which are particularly important in certain ethnicities. It enables rapid identification of patients who are unlikely to respond to Clopidogrel, in time-critical emergency healthcare settings where rapid appropriate antiplatelet prescription is crucial. The Genedrive® CYP2C19 ID Kit rapid test is best in class, recommended by the National Institute for Health and Care Excellence ("NICE") as the rapid genotyping platform of choice for use in the NHS, with dominant health economics, wider patient group coverage, and performance shown to be superior to laboratory testing methods.お知らせ • May 05genedrive plc Announces CYP2C19 ID Kit CE-IVD Certification Updategenedrive plc announces that the Notified Body responsible for its certification under the European In Vitro Diagnostic Regulation (IVDR 2017/746) has informed the Company that whilst expedited significantly, the review and subsequent independent certification process of the Genedrive® CYP2C19 ID Kit has been delayed by approximately one month.お知らせ • Apr 01genedrive plc has completed a Follow-on Equity Offering in the amount of £0.226309 million.genedrive plc has completed a Follow-on Equity Offering in the amount of £0.226309 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 15,087,261 Price\Range: £0.015お知らせ • Mar 28genedrive plc has filed a Follow-on Equity Offering.genedrive plc has filed a Follow-on Equity Offering. Security Name: Ordinary Shares Security Type: Common Stock Price\Range: £0.015お知らせ • Mar 27genedrive plc has filed a Follow-on Equity Offering in the amount of £1 million.genedrive plc has filed a Follow-on Equity Offering in the amount of £1 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 66,666,666 Price\Range: £0.015お知らせ • Dec 07genedrive plc, Annual General Meeting, Dec 30, 2024genedrive plc, Annual General Meeting, Dec 30, 2024. Location: the incubator building, grafton street, m13 9xx, manchester United Kingdomお知らせ • Nov 22genedrive plc to Report Fiscal Year 2024 Results on Nov 29, 2024genedrive plc announced that they will report fiscal year 2024 results at 8:00 AM, GMT Standard Time on Nov 29, 2024お知らせ • Nov 21genedrive plc Announces Successful Funding Award to Its Clinical Partners from the National Institute for Health and Care Research in Collaboration with the UK Government Office for Life Sciencesgenedrive plc announced a successful funding award to its clinical partners from the National Institute for Health and Care Research (NIHR) in collaboration with the UK Government Office for Life Sciences (OLS) to address evidence generation requirements of the National Institute for Health and Care Excellence ("NICE") Early Value Assessment ("EVA") for the Genedrive® MT-RNR1 ID kit. The NIHR/OLS Real World Evidence Programme is aimed specifically at technologies like the Genedrive® MT-RNR1 ID kit which have been recommended for use in the NHS via the NICE EVA, to enable the addressing of real-world evidence gaps and the potential subsequent provision of a full (non-conditional) recommendation by NICE to accelerate the widespread adoption and implementation into the NHS. The programme is clinician consortia-based and will be led by principal investigators Professor Bill Newman and Dr. John McDermott (University of Manchester /Manchester University NHS Foundation Trust), with 14 separate hospital Neonatal Intensive Care Units across England (inclusive of some sites which have already implemented the Genedrive® MT-RNR1 ID test as part of routine clinical use), Scotland, Wales and Northern Ireland (inclusive of nine sites already utilising the Genedrive® MT-RNR1 ID test in routine clinical practice). The start date was 1 November 2024 with a maximum duration of 18 months, with sites phased into group 1 (sites already currently using the test) and group 2 (remaining sites). Group 1 site testing is funded under the programme for six months from project initiation, following which funding for continuity of routine clinical practice will be required to be sought from alternative sources by those sites. Revenue to Genedrive for the MT-RNR1 ID kit under the programme is expected to be approximately £500,000. Whilst scheduled for a maximum of 18 months, performance data can be submitted to the NICE EVA Evidence Generation team at an earlier point if the team believes the evidence generation requirements have been successfully fulfilled. Performance data generated during the programme is also expected to contribute towards clinical performance data requirements for FDA as part of planned De novo submission process required for commercial entry into the U.S.New Risk • Oct 14New minor risk - Financial data availabilityThe company's latest financial reports are more than 6 months old. Last reported fiscal period ended December 2023. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (68% average daily change). Shareholders have been substantially diluted in the past year (416% increase in shares outstanding). Revenue is less than US$1m (UK£272k revenue, or US$355k). Minor Risks Latest financial reports are more than 6 months old (reported December 2023 fiscal period end). Market cap is less than US$100m (€16.2m market cap, or US$17.7m).お知らせ • Aug 06Genedrive plc Announces CEO Changesgenedrive plc announced that its Chief Executive Officer ("CEO"), James Cheek, has left the Company with immediate effect by mutual agreement. James has been succeeded as CEO by Dr. Gino Miele PhD, currently Chief Scientific Officer ("CSO") who has been with the Company since 2011, serving as R&D Director and since September 2023 as CSO and an Executive Board Director. Prior to joining the Company Gino served as an Associate Director for clinical translational genomics at Wyeth and Pfizer. Gino has been a key driver in the development of the genedrive instrumentation and products, positioning the Company at the forefront of pharmacogenomic testing in emergency healthcare settings and with the wider team has facilitated regulatory approval processes for the products throughout the UK, Europe and the Middle East. Gino was instrumental in the NICE approval processes for both the Genedrive® MT-RNR1 ID Kit and the Genedrive® CYP2C19 ID Kit, securing the Group's clinical trial agreement in the U.S., the recent FDA breakthrough device designation, and together with the genedrive commercial team is actively involved in generating a growing list of revenue opportunities in the UK and more widely.お知らせ • Jul 15Genedrive plc Receives Breakthrough Device Designation from the U.S. Food and Drug Administrationgenedrive plc announced that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration for the Genedrive® MT-RNR1 ID Kit. The Genedrive® MT-RNR1 kit is the world's first rapid point-of-care test to screen infants in an urgent care setting for a genetic variant that can cause life-long hearing loss when carriers of the variant are given certain antibiotics. Those infants identified by the Genedrive® MT-RNR1 ID kit as carrying the variant can then be given alternative antibiotics. It has the potential to save thousands of children from lifelong hearing loss, whilst providing a net positive financial outcome case to healthcare systems. The Breakthrough Devices Program1 is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorisation. Breakthrough Devices must meet the FDA's standards for device safety and effectiveness in order to be authorised for marketing. Devices subject to premarket approval applications ("PMA"), premarket notification 510(k), or requests for De Novo classification request are eligible for Breakthrough Device Designation if the device meets FDA criteria that it "provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions", in addition to "there being No Approved or Cleared Alternatives" and "Device Availability being in the Best Interest of Patients". The Breakthrough Devices Program offers manufacturers an opportunity to interact with FDA experts through several different programme options to efficiently address topics as they arise during the premarket review phase. This interaction can help manufacturers receive feedback from the FDA and identify areas of agreement in a timely way. Manufacturers can also expect prioritised review of their submission In 2021, 3.7 million babies were born in the USA, with 10.5% born prematurely. It was estimated that malpractice litigation settlements in cases related to deafness caused by the use of aminoglycosides average over US$1.1 million per case, further adding to the positive health economic case of providing accurate and timely testing to reduce unwanted side effects of gentamicin usage. Extrapolating from UK figures, the Company estimates that approximately 1,000 babies per annum in U.S. Neonatal Intensive Care Units ("NICU") are at risk of aminoglycoside induced hearing loss. Genedrive intends to pursue the FDADe Novoregulatory pathway for entry into the U.S. market. The FDA De Novo pathway provides a vehicle for establishing new predicate devices that can reflect modern standards for performance and safety and can serve as a basis for future clearances. De Novo classification is a risk-based classification process used when there is a lack of a predicate device already cleared by the FDA.お知らせ • May 31genedrive plc has completed a Follow-on Equity Offering in the amount of £6 million.genedrive plc has completed a Follow-on Equity Offering in the amount of £6 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 138,799,994 Price\Range: £0.015 Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 135,177,430 Price\Range: £0.015 Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 126,022,576 Price\Range: £0.015 Transaction Features: Regulation S; Rights Offering; Subsequent Direct Listingお知らせ • May 11genedrive plc has filed a Follow-on Equity Offering in the amount of £3.5 million.genedrive plc has filed a Follow-on Equity Offering in the amount of £3.5 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 233,333,333 Price\Range: £0.015 Transaction Features: Regulation SNew Risk • Apr 06New major risk - Shareholder dilutionThe company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 55% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-UK£3.9m free cash flow). Share price has been highly volatile over the past 3 months (83% average weekly change). Shareholders have been substantially diluted in the past year (55% increase in shares outstanding). Revenue is less than US$1m (UK£272k revenue, or US$344k). Minor Risk Market cap is less than US$100m (€10.6m market cap, or US$11.5m).お知らせ • Mar 16genedrive plc to Report First Half, 2024 Results on Mar 28, 2024genedrive plc announced that they will report first half, 2024 results on Mar 28, 2024New Risk • Feb 07New major risk - Market cap sizeThe company's market capitalization is less than US$10m. Market cap: €9.25m (US$9.94m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-UK£3.9m free cash flow). Share price has been highly volatile over the past 3 months (57% average daily change). Revenue is less than US$1m (UK£55k revenue, or US$69k). Market cap is less than US$10m (€9.25m market cap, or US$9.94m). Minor Risk Shareholders have been diluted in the past year (45% increase in shares outstanding).お知らせ • Dec 07genedrive plc, Annual General Meeting, Dec 29, 2023genedrive plc, Annual General Meeting, Dec 29, 2023, at 10:00 Coordinated Universal Time. Location: 46-48 Grafton Street Manchester United KingdomReported Earnings • Dec 01Full year 2023 earnings released: UK£0.055 loss per share (vs UK£0.055 loss in FY 2022)Full year 2023 results: UK£0.055 loss per share (in line with FY 2022). Net loss: UK£5.15m (loss widened 10% from FY 2022).New Risk • Nov 21New major risk - Market cap sizeThe company's market capitalization is less than US$10m. Market cap: €9.15m (US$9.99m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (22% average weekly change). Revenue is less than US$1m (UK£68k revenue, or US$85k). Market cap is less than US$10m (€9.15m market cap, or US$9.99m). Minor Risks Latest financial reports are more than 6 months old (reported December 2022 fiscal period end). Shareholders have been diluted in the past year (17% increase in shares outstanding).お知らせ • Nov 17genedrive plc to Report Fiscal Year 2023 Results on Nov 30, 2023genedrive plc announced that they will report fiscal year 2023 results on Nov 30, 2023New Risk • Oct 18New minor risk - Financial data availabilityThe company's latest financial reports are more than 6 months old. Last reported fiscal period ended December 2022. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (20% average weekly change). Revenue is less than US$1m (UK£68k revenue, or US$83k). Minor Risks Latest financial reports are more than 6 months old (reported December 2022 fiscal period end). Shareholders have been diluted in the past year (14% increase in shares outstanding). Market cap is less than US$100m (€11.7m market cap, or US$12.3m).お知らせ • Sep 12genedrive plc Announces Chief Executive Officer Changesgenedrive plc announced the appointment of James Cheek as Chief Executive Officer of the Company. James will take up the positions and will succeed David Budd, who has notifiecd the Company of his intention to step down from the role with immediate effect. James brings extensive commercial and operational experience at a senior level through a successful career with established diagnostic companies such as Cepheid, Beckman Coulter, and Roche Diagnostics, as well as serving as an executive board member of the British In Vitro Diagnostics Association (BIVDA). The Board believes James' experience, especially his extensive involvement in selling into the NHS, will be valuable as the Company expands its commercial footprint and opportunities within the UK and more widely.お知らせ • Sep 06Genedrive plc Achieves UKCA Marking Registration for its New Genedrive CYP2C19 Systemgenedrive plc announced it has achieved UKCA marking registration for its new Genedrive CYP2C19 System. It is a point of care pharmacogenomic test that can differentiate between patients that could respond to clopidogrel treatment and those that will not, allowing more effective drug treatment to be prescribed on a personalised basis. The test can be performed at the bedside or in a ward, and can deliver a clinically actionable result in about one hour. Poor response to treatment following stroke is common, effecting up to 30% of patients in the general population and in a recent report up to 50% in certain ethnic groups. In the UK, the National Institute for Health and Care Excellence ("NICE") recommended in May 2023 draft guidance that people who have had an ischaemic stroke or transient ischaemic attack ("TIA") should have a CYP2C19 genetic test prior to treatment. It's estimated that there are over 60 million ischaemic strokes per year globally and over 100,000 in the UK each year. The Genedrive®? CYP2C19 test uses a single, non-invasive cheek swab sample, and rapidly identifies six important genetic variants of the CYP2C19 gene, which are instrumental in the loss of metabolism function and poor activation of clopidogrel in a patient. The Genedrive System automatically interprets the information for the clinician, allowing prompt administration of an optimised treatment plan. Like all genedrive products, the tests are presented in a temperature stable, freeze-dried format, allowing testing to be performed by healthcare workers, away from laboratory locations. In its performance evaluations, the test achieved 99% accuracy in detecting the variants that underpin loss of metabolism function. UKCA marking now allows the Company to begin commercialisation in the UK, and actively engage in the DEVOTE programme (previously announced in May 2023), which will generate additional performance data in an acute care setting. This expanded dataset is required for CE marking submission, which will allow for commercialisation in the EU. Submission is expected in the first half of 2024 once genedrive's engagement with DEVOTE has completed. In the United Kingdom, the Company will be selling the product through its direct sales team, and momentum for adoption is expected to be influenced by positive final NICE recommendations for CYP2C19 testing, which are expected in December 2023.お知らせ • Dec 06genedrive plc, Annual General Meeting, Dec 29, 2022genedrive plc, Annual General Meeting, Dec 29, 2022, at 11:00 Coordinated Universal Time. Location: 46 Grafton Street, Manchester M13 9XX Manachester United KingdomReported Earnings • Nov 22Full year 2022 earnings released: UK£0.055 loss per share (vs UK£0.012 loss in FY 2021)Full year 2022 results: UK£0.055 loss per share (further deteriorated from UK£0.012 loss in FY 2021). Net loss: UK£4.68m (loss widened UK£3.98m from FY 2021).お知らせ • Nov 14genedrive plc to Report Fiscal Year 2022 Results on Nov 21, 2022genedrive plc announced that they will report fiscal year 2022 results on Nov 21, 2022お知らせ • Oct 06genedrive plc Files US FDA Pre-Submission for the Genedrive® MT-RNR1 Product Rangegenedrive plc announced that it has commenced engagement with the U.S. Food and Drug Administration ("FDA") to progress the regulatory approval of the Genedrive® MT-RNR1 ID Kit into the USA. The Genedrive® MT-RNR1 assay is the world's first rapid point-of-care test to screen infants in an urgent care setting for a genetic variant that will cause life-long hearing loss when carriers of the variant are given certain antibiotics. Those that carry the variant can then be given alternative treatments following detection of the variant by the Genedrive® MT-RNR1 test. It has the potential to save thousands of children from lifelong hearing loss, whilst providing a net positive financial outcome case to healthcare systems. genedrive has submitted via the FDA's Pre-Submission process because there is no exact comparable test in the market already. The Pre-Sub process allows the Company an opportunity to clarify its testing and validation approach, confirm the appropriate regulatory application pathway (510(k) vs De Novo application) and gain additional procedural feedback from the FDA with the aim of making the final submission process more efficient. In 2021, 3.7 million babies were born in the USA, with 10.5% born prematurely. It was estimated that malpractice litigation settlements in cases related to deafness caused by the use of aminoglycosides average over USD 1.1 million per case, further adding to the positive health economic case of providing accurate and timely testing to reduce unwanted side effects of gentamicin usage.お知らせ • Aug 22Genedrive plc Announces UK's National Institute for Health and Clinical Excellence Commences an Evaluation of CYP2C19 Genotype Testing for Clopidogrel Treatmentgenedrive plc announced that the UK's National Institute for Health and Clinical Excellence has commenced an evaluation of CYP2C19 genotype testing for Clopidogrel treatment, via a new NICE Diagnostics Assessment Programme. Genedrive's CYP2C19 ID Kit, currently in development, has been included in the assessment. Both of genedrive's new emergency Point of Care genetic screening tests are now included in new NICE reviews, following the MT-RNR1 DAP announcement on 16 June 2022. Clopidogrel is a drug that is given to ischemic stroke patients to prevent further clot formation. The CYP2C19 gene is involved in a metabolic pathway in the liver that converts Clopidogrel to its active form. Clopidogrel is less effective in individuals with certain genetic CYP2C19 variants because they do not metabolize Clopidogrel fully. As a consequence, it has a reduced impact on lowering the risk of a further stroke. Genedrive's CYP2C19 ID Kit, can provide guidance on which patients will respond to Clopidogrel. Patients with gene variants that result in reduced or loss of function of CYP2C19 can be given alternative treatments. The Genedrive® CYP2C19 test is a simple, rapid point of care test, with no requirement for result interpretation and provides results in a clinically actionable timeframe. The genedrive test has been designed to have extended coverage across ethnic populations, which is important because the frequency of the various CYP2C19 related genetic changes differs across ethnicities. DAP evaluations are designed to provide robust recommendations on the use of new products, which is presented in the form of NICE guidance, and to promote rapid and consistent adoption of clinically innovative and cost-effective diagnostic technologies in the NHS. The DAP will assess the clinical and cost-effectiveness of Clopidogrel genotype testing, including any advantages of point of care testing vs central lab-based testing, in order to make recommendations on its use in the NHS. The international CPIC guideline for Clopidogrel and CYP2C19 was recently updated (January 2022). The guidelines are based on clinical evidence and peer-reviewed literature. The clinical landscape for genetically guided anti-platelet therapy can be considered to be at a more advanced stage compared to many other genetic areas. Genedrive's new CYP2C19 Kit is targeted for completion in First Quarter 2023 and will require approval under the new IVDR regulations.お知らせ • Jun 16NICE to Evaluate the Genedrive MT-RNR1 Testgenedrive plc announced that the UK's National Institute for Health and Clinical Excellence ('NICE') has started an evaluation of the Genedrive® MT-RNR1 test via their Diagnostics Assessment Programme ('DAP'). DAP evaluations are designed to provide robust recommendations on the use of new products, which is presented in the form of NICE guidance, and to promote rapid and consistent adoption of clinically innovative and cost-effective diagnostic technologies in the NHS. An independent advisory committee considers the evidence provided, makes draft recommendations for public consultation and ultimately makes final recommendations for publication in NICE guidance. The guidance produced is used by NHS commissioners, practitioners, healthcare operational managers and purchasing and procurement organisations. genedrive's assay is the world's first rapid point of care test to screen infants in an urgent care setting for a genetic variant that will cause life-long hearing loss when carriers of the variant are given certain antibiotics. Those that carry the variant can then be given alternative treatments following detection of the variant by the Genedrive® MT-RNR1 test.Board Change • May 31High number of new directorsChief Financial Officer & Director Russ Shaw was the last director to join the board, commencing their role in 2022.お知らせ • May 31Genedrive plc Announces Point-Of-Care Cov19-Id Kit Receives CTDA Approval from Medicines and Healthcare Products Regulatory Agencygenedrive plc announces that the UK Medicines and Healthcare Products Regulatory Agency has granted a CTDA enabling the sale of the Genedrive® COV19-ID Kit in the United Kingdom. Genedrive's application for approval, under the requirements that came into force on 28 July 2021 via The Medical Devices (Coronavirus Test Device Approvals Regulations (2021)), was made on 21 December 2021. Since submission for approval, the product has undergone positive external validation, commercial partners have been engaged in specific countries, and product claims have been expanded to include the testing of asymptomatic patients. The Genedrive® COV19-ID Kit is a rapid molecular diagnostic test that delivers positive results as quickly as 7.5 minutes and negative results at 17 minutes. It utilises Reverse-Transcription Loop Mediated Isothermal Amplification (RT-LAMP) and a proprietary buffer formulation to achieve rapid results without requirement for user viral extraction steps. Performed directly from a mid-turbinate nasal swab, the assay targets the ORF1ab and N genes of the SARS-CoV-2 genome, adding robustness against emerging SARS-CoV-2 variants.Board Change • Apr 27High number of new directorsChief Financial Officer & Director Russ Shaw was the last director to join the board, commencing their role in 2022.Buying Opportunity • Apr 06Now 24% undervaluedOver the last 90 days, the stock is up 3.8%. The fair value is estimated to be €0.50, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has declined by 55% over the last 3 years. Earnings per share has grown by 26%.Reported Earnings • Mar 30First half 2022 earnings releasedFirst half 2022 results: Net income: (down UK£991.0k from profit in 1H 2021).お知らせ • Mar 30Genedrive plc Announces NICE issues Medtech Innovation Briefing on Genedrive ® MT-RNR1 Testgenedrive plc announced that the UK's National Institute of Clinical Excellence (NICE) has issued a new Medtech Innovation Briefing (MIB) on the Genedrive® MT-RNR1 test. genedrive's assay is the world's first point of care test to screen infants in an urgent care setting for a genetic variant that will cause life-long hearing loss when carriers of the variant are given certain antibiotics. Those that carry the variant can then be given alternative treatments following detection of the variant by the Genedrive® MT-RNR1 test. The Medtech Innovation Briefing is an important step to increase awareness in the NHS of new innovation and ultimately support adoption in the UK.お知らせ • Mar 03genedrive plc Announces Resignation of Matthew Fowler as Group's Chief Financial Officergenedrive plc announced that Matthew Fowler, the group's chief financial officer, will be leaving the company and stepping down from the board on April 19, 2022. This follows the announcement on November 16, 2021 that Matthew Fowler intended to stand down after five years in the role, in order to take up a position as chief financial officer of musicMagpie plc.お知らせ • Feb 24Genedrive plc Provides Update on Point of Care Covid Testgenedrive plc provides an update on the progress being made on the Genedrive®?COV19-ID kit, its rapid point of care molecular test for Covid-19. The Genedrive® COV19-ID kit is a rapid molecular diagnostic test that delivers positive results as quickly as 7.5 minutes and negative results at 17 minutes. It utilises Reverse-Transcription Loop Mediated Isothermal Amplification (RT-LAMP) and a proprietary buffer formulation to achieve rapid results without viral extraction. Performed directly from a mid-turbinate nasal swab, the assay targets the ORF1ab and N genes of the SARS-CoV-2 genome, adding robustness against emerging SARS-CoV-2 variants. The product was CE marked on 8 December 2021 and was subsequently sent for evaluation purposes to interested parties. The Company has now entered into distribution agreements covering Spain, Portugal, Oman and the United Arab Emirates, with other opportunities continuing to be assessed in other EU countries. The customer base that distributors are targeting is consistent with those that the Company has previously announced, including pharmacies, sports and private workplaces. Market requirements differ from country to country depending on government policies and legislation. These initial distributor arrangements are designed to both access and assess the longer-term market potential in each country. The Company also has end-user product evaluation ongoing in the United Kingdom to access specific occupational health markets. The product cannot be commercially sold yet in the UK, as CTDA approval is still pending. With UK government statutory requirements for COVID testing changing rapidly, future opportunities would be discretionary testing vs government mandates. The Company will continue with its commercial steps to build its sales pipeline and grow revenues and will provide updates as appropriate both on sales and material new distributor engagements.お知らせ • Feb 04genedrive plc to Report First Half, 2022 Results on Mar 29, 2022genedrive plc announced that they will report first half, 2022 results on Mar 29, 2022お知らせ • Dec 23genedrive plc Announces UK CTDA application for Point-of-Care Genedrive®?COV19-ID kitgenedrive plc further to the announcement on 29 November 2021 confirming submission for CE-IVD certification for the Genedrive® COV19-ID Kit, expanded product validation requirements have now been completed and the Company has filed for approval to sell the product in the United Kingdom under the new Coronavirus Test Device Approvals (CTDA) regulations. CTDA regulations came into effect on 1 Nov. 2021 and place specific registration, review and performance requirements on suppliers of COVID-19 diagnostic products into the United Kingdom. The expanded clinical validation sample cohort required for CTDA approval was referenced against the Thermo Fisher TaqPath COVID-19 RT-PCR test. In the 264 samples, specificity was 98%, and sensitivity was 98% in samples with viral load >500 copies per ml. This cohort included samples of confirmed Omicron variant, all of which were successfully detected. The sensitivity and specificity of the Genedrive® COV19-ID assay on the entire cohort met the current requirements of the UK's MHRA Target Product Profile for SARS-CoV-2 Point-of-Care molecular diagnostic tests. The Genedrive® COV19-ID kit is a rapid molecular diagnostic test that delivers positive results as quickly as 7.5 minutes and negative results at 17 minutes. It utilises Reverse-Transcription Loop Mediated Isothermal Amplification (RT-LAMP) and a proprietary buffer formulation to achieve rapid results without requirement for user viral extraction steps. Performed directly from a mid-turbinate nasal swab, the assay targets the ORF1ab and N genes of the SARS-CoV-2 genome, adding robustness against emerging SARS-CoV-2 variants.Reported Earnings • Nov 10Full year 2021 earnings released: UK£0.012 loss per share (vs UK£0.55 loss in FY 2020)The company reported a decent full year result with reduced losses and improved control over expenses, although revenues were weaker. Full year 2021 results: Revenue: UK£687.0k (down 35% from FY 2020). Net loss: UK£691.0k (loss narrowed 96% from FY 2020).Board Change • Sep 02Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 5 experienced directors. No highly experienced directors. Independent Non-Executive Director Chris Henry Yates was the last director to join the board, commencing their role in 2018. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.お知らせ • Jul 02Genedrive COVID-19 Point of Care device updategenedrive plc provides an update on the development of its Genedrive® COV19-ID Kit, a rapid Point of Care (PoC) molecular test for SARS-CoV-2 detection, designed for the Company's Genedrive® instrument. The Company has been developing a new, best-in-class PoC molecular workflow and assay for more than 9 months. The Company is pleased to release the product's current performance specifications as it moves towards the stages of formal clinical qualification and regulatory filing. While acknowledging the longer than anticipated development time, the Company has overcome significant technical hurdles and also further improved performance specifications alongside evolving marketplace requirements. Key specifications of sensitivity, specificity, speed, ease of use, and scalability have all been improved or addressed. The Genedrive® COV19-ID Kit detects the presence of SARS-CoV-2 virus in a nasal swab. The product has been designed to provide an ease of use appropriate for people inexperienced in molecular testing. Positive samples are detected as quickly as 9-10 minutes, with a negative result reported after 20 minutes if no signal is detected. In contrast to many competitor products, the test targets two genes of the SARS-CoV-2 genome, and is shown to be inclusive of all current Variants of Concern (VoCs), including the Delta variant. The intent of a two-gene design is to provide additional robustness to new emerging VoCs in the future. The specificity of the test during design verification (30 positive and 30 negative contrived clinical samples) was 100%, with a PCR comparable limit of detection of 10-20 copies per reaction. The testing procedure does not require extraction of the virus from the patient's sample. The Company has developed a proprietary lysis buffer that is used to resuspend patient swab material, while providing biosafety to users. Exact quantification of biosafety is currently being assessed in an independent UK Public Health England laboratory. A fully biosafe process would present additional or novel opportunities and use-cases for PoC COVID-19 testing. The simple, 4-step workflow uses an 'eye-dropper' liquid transfer process familiar from lateral flow testing, and makes the system appropriate for use by those without previous molecular experience.Reported Earnings • Mar 28First half 2021 earnings released: EPS UK£0.019 (vs UK£0.089 loss in 1H 2020)First half 2021 results: Revenue: UK£355.0k (down 43% from 1H 2020). Net income: UK£991.0k (up UK£4.03m from 1H 2020).お知らせ • Mar 09genedrive plc Enters Distribution Agreement with Mountain Horse Solutionsgenedrive plc announced that it has entered into an agreement for the distribution of the company's military pathogen detection assays in the United States with Mountain Horse Solutions.お知らせ • Mar 04genedrive plc Provides an Update on its Antibiotic Induced Hearing Loss Assaygenedrive plc provided an update on its Antibiotic Induced Hearing Loss (AIHL) assay. As announced on the 3 December 2020, an 11 month implementation trial at Manchester University NHS Foundation Trust and Liverpool Women's Hospital successfully concluded in November 2020. The results of the study will be published in a peer reviewed journal. The study's primary outcomes were very positive, showing genedrive's utility as the world's first rapid genetic test in an emergency care neonatal setting. In excess of 750 babies were tested and 160 hospital staff were trained to provide rapid testing in this critical care setting. Since completion of the trial, there has been new clinical guidance in the UK1on the importance of the management of specific genetic mutations and their role in hearing loss as a result of antibiotics (ototoxicity). Government and Society guidance are considered a key factor influencing the speed and extent of future adoption. The Company and Inspiration Healthcare Group plc (AIM: IHC), the distribution partner for the AIHL assay, believe this will lead to increased demand for the genedrive AIHL test in the UK. This new government guidance reminds healthcare professionals about the impact of antibiotic related ototoxicity and to consider the need for genetic testing prior to initiation of treatment. genedrive's assay is the only commercial point of care test available for the testing of MT-RNR1, the most important mutation contributing to AIHL in infants. The launch of the genedrive AIHL assay remains on track for summer 2021 and the Company is enthusiastic about both the commercial prospects and the clinical benefits of this novel test to prevent potential irreversible hearing loss and this test becoming a standard of care. The Company is executing initial stage key opinion leader engagement in the UK alongside Inspriration Healthcare in preparation for commercial launch.Is New 90 Day High Low • Feb 07New 90-day high: €1.05The company is up 48% from its price of €0.71 on 09 November 2020. The German market is up 15% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Life Sciences industry, which is up 3.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €0.27 per share.お知らせ • Jan 29genedrive plc Enters into Distribution Agreement with Beckman Coulter Life Sciencesgenedrive plc announced that it has entered into a distribution agreement with Beckman Coulter Life Sciences ("Beckman Coulter") for its Genedrive 96 SARS-CoV-2 Kit. The agreement enables Beckman Coulter to sell and distribute genedrive's high-throughput COVID-19 PCR Kit in the United States and Europe for use on upper respiratory viral samples. The agreement is the result of the collaboration agreement announced in August 2020, under which the companies worked to develop and validate a fully automated PCR process for Beckman Coulter's Biomek automated workstation in conjunction with its RNAdvance Viral XP extraction kit. The Genedrive 96 SARS-CoV-2 test is ideally suited for use on the high throughput robotic Biomek i7 instrument. The ready-to-go nature of the test removes many of the fluid dispensing steps required in competitor assays, increasing the overall throughput of the Biomek compared to using a liquid reagent based test formulation. Full automation of the overall PCR workflow can allow laboratories to run large numbers of tests over extended working hours or workstation platforms. Beckman Coulter estimates that this new turnkey solution could process circa 1,000 PCR samples per Biomek workstation installed during a standard 8-hour working day, using just a 0.5 full-time-equivalent in technician time for processing.お知らせ • Jan 19genedrive plc to Report First Half, 2021 Results on Mar 25, 2021genedrive plc announced that they will report first half, 2021 results on Mar 25, 2021Is New 90 Day High Low • Jan 14New 90-day low: €0.32The company is down 75% from its price of €1.31 on 16 October 2020. The German market is up 10.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Life Sciences industry, which is up 1.0% over the same period.お知らせ • Jan 01genedrive plc, Annual General Meeting, Dec 30, 2020genedrive plc, Annual General Meeting, Dec 30, 2020. Agenda: To consider and receive the annual report and accounts for the company; to approve the directors remuneration report; to re-appoint Tom Lindsay as a director; to re-appoint Chris Yates as a director; to re-appoint David Budd as a director; to re-appoint Matthew Fowler as a director; to re-appoint Ian Gilham as a director; to re-appointment of RSM UK as auditors of the company; to consider directors authority to allot shares; and to consider disapplication of pre-emption rights.Is New 90 Day High Low • Dec 12New 90-day low: €0.37The company is down 56% from its price of €0.83 on 11 September 2020. The German market is up 1.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Life Sciences industry, which is up 3.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €0.19 per share.お知らせ • Dec 04Genedrive plc Announces Successful Completion of the Antibiotic Induced Hearing Loss Implementation StudyGenedrive plc announced the successful completion of the Antibiotic Induced Hearing Loss implementation study into the use of the genetic test in an NHS neonatal intensive care setting. The Genedrive MT-RNR1 ID Kit has been used over the past 11 months in a trial of what is thought to be a world first use of a genetic test in a neonatal intensive care setting. The Genedrive assay has been used at Manchester University NHS Foundation Trust and Liverpool Women's Hospital to screen babies before administering certain antibiotics that are known to cause deafness in infants. Over the period of the study, approximately 750 babies have been tested with the Genedrive MT-RNR1 Kit, with all valid results being confirmed by DNA sequencing. Genedrive is now working with the study team to publish the data, due in early 2021, and with Inspiration Healthcare plc to plan the roll-out for commercial use. Full launch of the product is expected from June 2021, following the inclusion of feedback from the trial sites in the product configuration.Analyst Estimate Surprise Post Earnings • Nov 30Revenue misses expectationsRevenue missed analyst estimates by 37%. Over the next year, revenue is forecast to grow 193%, compared to a 18% growth forecast for the Life Sciences industry in Germany.Reported Earnings • Nov 30Full year 2020 earnings released: UK£0.55 loss per shareThe company reported a poor full year result with increased losses and weaker revenues and control over expenses. Full year 2020 results: Revenue: UK£1.06m (down 55% from FY 2019). Net loss: UK£19.4m (loss widened 434% from FY 2019).お知らせ • Nov 20Genedrive Announces HCV ID Kit Demonstrates High Clinical Accuracy in India Studygenedrive plc announces the publication of the study data for the 'Evaluation of the Point of Care Molecular Diagnostic Genedrive HCV ID Kit for the detection of HCV RNA in clinical samples. The study was led by Dr Ekta Gupta at ILBS, New Delhi, India. The objective of the study was to determine the diagnostic accuracy of the Genedrive HCV ID Kit, as a confirmatory test for seropositive hepatitis C virus (HCV) patients in Indian demographic settings. The diagnostic accuracy of the Genedrive HCV ID Kit was evaluated by comparing the test with the Abbott Real time HCV test on the lab-based Abbott m2000 platform in an Indian demographic and across a range of different genotypes, to ensure suitability for introduction of the product to the Indian population. In India the circulation of HCV genotype is predominantly genotypes 3 and 1 with live infections of HCV estimated at between 6-12 million.Reported Earnings • Nov 19Full year 2020 earnings released: UK£0.55 loss per shareThe company reported a poor full year result with increased losses and weaker revenues and control over expenses. Full year 2020 results: Revenue: UK£1.06m (down 55% from FY 2019). Net loss: UK£19.4m (loss widened 434% from FY 2019).Analyst Estimate Surprise Post Earnings • Nov 19Revenue misses expectationsRevenue missed analyst estimates by 37%. Over the next year, revenue is forecast to grow 315%, compared to a 17% growth forecast for the Life Sciences industry in Germany.Is New 90 Day High Low • Nov 09New 90-day low: €0.71The company is down 19% from its price of €0.88 on 11 August 2020. The German market is down 1.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Life Sciences industry, which is up 16% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €0.21 per share.お知らせ • Oct 29genedrive plc to Report Fiscal Year 2020 Results on Nov 17, 2020genedrive plc announced that they will report fiscal year 2020 results on Nov 17, 2020お知らせ • Oct 04genedrive plc Announces South African Approvalgenedrive plc announced that the Company's Genedrive® 96 SARS-CoV-2 Kit has received approval from the South African Health Products Regulatory Authority. The Genedrive® kit was submitted for evaluation in June 2020. Under the approval, the Kit can now be distributed and sold within South Africa. Genedrive products are supplied in the country, and more broadly within Africa, via the Sysmex EMEA organisation. Since the original evaluation, genedrive has expanded the number of PCR platforms and RNA isolation kit providers which are validated for the Company's Kit. This is important for markets such as South Africa where high testing volumes are supported by the prevalence of automated/robotic RNA extraction instruments, and the variety of testing platforms is diverse owing to a split between public and private testing facilities.お知らせ • Sep 26genedrive plc Announces Completes Initial Testing of Beckman Coulter Life Sciences' Rnadvance Viral RNAgenedrive plc announced that has completed initial testing of Beckman Coulter Life Sciences' RNAdvance Viral RNA extraction chemistry on respiratory swabs in conjunction with its COVID-19 PCR test. The sensitivity in using the Genedrive Kit with samples from upper respiratory swabs is equivalent to the existing Genedrive SARS-CoV-2 Kit specification claim, indicating the Beckman product is suitable for use in the Genedrive testing workflow. The Beckman RNAdvance kit has now been added to the Genedrive 96 SARS-CoV2 Instruction for Use as a validated extraction protocol for swabs. This is an important technical milestone in transitioning the Genedrive® 96 SARS-CoV-2 Kit to a fully automated workflow using Beckman's RNA extraction and Biomek automated workstation.Is New 90 Day High Low • Sep 22New 90-day high: €1.48The company is up 16% from its price of €1.28 on 24 June 2020. The German market is up 4.0% over the last 90 days, indicating the company outperformed over that time. However, it underperformed the Life Sciences industry, which is up 22% over the same period.収支内訳genedrive の稼ぎ方とお金の使い方。LTMベースの直近の報告された収益に基づく。収益と収入の歴史DB:D6M 収益、費用、利益 ( )GBP Millions日付収益収益G+A経費研究開発費31 Dec 251-52030 Sep 251-52030 Jun 251-52031 Mar 251-62031 Dec 241-72030 Sep 241-72030 Jun 241-72031 Mar 240-62031 Dec 230-51030 Sep 230-51030 Jun 230-51031 Mar 230-51031 Dec 220-52030 Sep 220-52030 Jun 220-52031 Mar 220-42031 Dec 210-42030 Sep 211-22030 Jun 211-12031 Mar 211-82031 Dec 201-152030 Sep 201-172030 Jun 201-192031 Mar 201-122031 Dec 192-52030 Sep 192-42030 Jun 192-42031 Mar 192-52031 Dec 182-72030 Sep 182-72030 Jun 182-72031 Dec 171-63030 Sep 172-63030 Jun 173-73031 Mar 176-62031 Dec 166-52030 Sep 166-62030 Jun 165-62031 Mar 165-52031 Dec 154-52030 Sep 154-42030 Jun 155-320質の高い収益: D6Mは現在利益が出ていません。利益率の向上: D6Mは現在利益が出ていません。フリー・キャッシュフローと収益の比較過去の収益成長分析収益動向: D6Mは利益を出していないが、過去 5 年間で年間1%の割合で損失を削減してきた。成長の加速: D6Mの過去 1 年間の収益成長を 5 年間の平均と比較することはできません。現在は利益が出ていないためです。収益対業界: D6Mは利益が出ていないため、過去 1 年間の収益成長をLife Sciences業界 ( 5.4% ) と比較することは困難です。株主資本利益率高いROE: D6Mの負債は資産を上回っているため、自己資本利益率を計算することは困難です。総資産利益率使用総資本利益率過去の好業績企業の発掘7D1Y7D1Y7D1YPharmaceuticals-biotech 、過去の業績が好調な企業。View Financial Health企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/05/24 17:44終値2026/05/22 00:00収益2025/12/31年間収益2025/06/30データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋genedrive plc 0 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。5 アナリスト機関Mark BrewerCavendishJohn SavinEdison Investment ResearchNigel Bligh HawkinsHardman & Co.2 その他のアナリストを表示
お知らせ • Dec 03genedrive plc to Report Fiscal Year 2025 Results on Dec 05, 2025genedrive plc announced that they will report fiscal year 2025 results at 8:00 AM, GMT Standard Time on Dec 05, 2025
お知らせ • Nov 22genedrive plc to Report Fiscal Year 2024 Results on Nov 29, 2024genedrive plc announced that they will report fiscal year 2024 results at 8:00 AM, GMT Standard Time on Nov 29, 2024
お知らせ • Mar 16genedrive plc to Report First Half, 2024 Results on Mar 28, 2024genedrive plc announced that they will report first half, 2024 results on Mar 28, 2024
Reported Earnings • Dec 01Full year 2023 earnings released: UK£0.055 loss per share (vs UK£0.055 loss in FY 2022)Full year 2023 results: UK£0.055 loss per share (in line with FY 2022). Net loss: UK£5.15m (loss widened 10% from FY 2022).
お知らせ • Nov 17genedrive plc to Report Fiscal Year 2023 Results on Nov 30, 2023genedrive plc announced that they will report fiscal year 2023 results on Nov 30, 2023
Reported Earnings • Nov 22Full year 2022 earnings released: UK£0.055 loss per share (vs UK£0.012 loss in FY 2021)Full year 2022 results: UK£0.055 loss per share (further deteriorated from UK£0.012 loss in FY 2021). Net loss: UK£4.68m (loss widened UK£3.98m from FY 2021).
お知らせ • May 06Genedrive Plc Transitions MT-RNR1 Test To Business As Usual Clinical ServiceGenedrive plc announced that, from 1 May 2026, University Hospitals Sussex NHS Foundation Trust hospitals transitioned to Business as Usual routine clinical service of the Genedrive MT-RNR1 ID kit for the prevention of Antibiotic Induced Hearing Loss in neonates admitted to Neonatal Intensive Care Units. UHS Royal County Sussex Hospital's Trevor Mann Baby Unit provides specialist care for approximately 400 NICU admissions annually and has been a participating site in the PALOH-UK programme, which aims to address National Institute for Clinical Care and Excellence Real World Evidence generation requirements. To date, nearly 40 babies in NICUs have been identified with the MT-RNR1 variant since introduction of the test in the UK, enabling alternative antibiotic prescription and reducing the risk of aminoglycoside-induced lifelong hearing loss. Funding for PALOH-UK sites is provided by the Office for Life Sciences and National Institute for Health and Care Research and will cease by June 2026, with some sites completing earlier. Subsequent review and issuance of final guidance by NICE is expected around July 2027. Genedrive has two CE-IVD approved and NICE-recommended tests in NHS clinical use. The Genedrive CYP2C19 ID Kit identifies stroke patients who will not respond to the current standard of care, Clopidogrel, used to reduce risk of secondary stroke. The Genedrive MT-RNR1 ID Kit helps prevent antibiotic-induced hearing loss in newborns, enabling treatment decisions within actionable timeframes at the point of care.
お知らせ • Apr 23Genedrive plc Announces Nhs England Commercial Strategy for Rapid Mt-Rnr1 TestingGenedrive plc (AIM: GDR), the point of care pharmacogenetic testing company, welcomed publication from NHS England of a Preliminary market engagement notice under the Procurement Act 2023, to inform the NHS commercial strategy for rapid genetic MT-RNR1 testing in neonates to prevent antibiotic induced hearing loss. To date, since introduction, the rapid MT-RNR1 test has been used as part of routine clinical practice by approximately 900 neonatal nurses for over 10,000 babies admitted to NICUs, enabling more than 30 to avoid lifelong hearing loss as a result of aminoglycoside antibiotic exposure. In the UK, Genedrive® MT-RNR1 ID kit is being implemented and used in the Neonatal Intensive Care Units ("NICU") of 14 hospitals across the four UK nations as part of a real world evidence generation programme (PALOH-UK) funded by the National Institute for Health and Care Research (NIHR) and the UK Government Office for Life Sciences (OLS). The test also has conditional recommendation for use in the NHS by the National Institute for Health and Care Excellence ("NICE") whilst further real world evidence is generated. Genedrive estimates that annual NICU admissions in these NICUs represent approximately 10% of admissions in the UK. Additionally, since October 2025, implementation of the Genedrive® MT-RNR1 ID kit into all NHS Scotland Health boards has been actively progressing under a phased implantation programme with the Accelerated National Innovation Adoption (ANIA) pathway led by the Scottish Centre for Sustainable Delivery. The PALOH-UK programme is scheduled to complete by July 2026, with subsequent NICE review and issuance of final guidance communicated to be approximately July 2027. Post PALOH-UK and ahead of final guidance, business case progression will continue as planned to enable PALOH-UK sites to rapidly transition to Business as Usual use. In addition to anticipated timelines, the premarket engagement notes anticipate a publication date of tender notice of 1 January 2027 and go-live target date of 1 July 2027, subject to NICE guidance outcome.
お知らせ • Mar 09genedrive plc has completed a Follow-on Equity Offering in the amount of £0.909643 million.genedrive plc has completed a Follow-on Equity Offering in the amount of £0.909643 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 90,964,264 Price\Range: £0.01 Transaction Features: Rights Offering
お知らせ • Feb 14+ 2 more updatesgenedrive plc has completed a Follow-on Equity Offering in the amount of £0.5 million.genedrive plc has completed a Follow-on Equity Offering in the amount of £0.5 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 50,000,000 Price\Range: £0.01 Transaction Features: Subsequent Direct Listing
お知らせ • Dec 09genedrive plc, Annual General Meeting, Dec 31, 2025genedrive plc, Annual General Meeting, Dec 31, 2025. Location: 46 grafton street, m13 9xx, manchester United Kingdom
お知らせ • Dec 03genedrive plc to Report Fiscal Year 2025 Results on Dec 05, 2025genedrive plc announced that they will report fiscal year 2025 results at 8:00 AM, GMT Standard Time on Dec 05, 2025
お知らせ • Dec 02genedrive plc Announces Pilot Programme Study Results Underpinning Nhs Implementation Guide for Cyp2c19 Genotype Testing Presented At the Uk Stroke Forumgenedrive plc notes the presentation of two posters by authors from NHS England ("NHSE") Network of Excellence in Pharmacogenomics, the NHSE Genomics Unit, NHSE National Stroke Programme, and Manchester Centre for Genomic Medicine at the UK Stroke Forum, Aberdeen, 25-27 November 2025. Data presented in these posters underpinned the recently published "NHS implementation guide for CYP2C19 genotype testing to guide Clopidogrel use after ischaemic stroke or transient ischaemic attack ("TIA") to support prescribing decisions in stroke. As outlined in the online presentation (Personalising Medicines with Genomics), the National Pilot Programme was conducted at four geographically diverse NHS stroke units across England. The results included laboratory CYP2C19 testing assessed at Doncaster, St. George's and Exeter (December 2024 - April 2025), and Point-of Care ("PoC") rapid CYP2C19 genetic testing assessed using the Genedrive®? CYP2C19 ID kit at Salford Royal Hospital's Hyper Acute Stroke Centre (March 2025 - April 2025). Key findings and conclusions from these were; A higher prevalence of patients unlikely to respond to clopidogrel identified in the near-patient arm (33%) versus the laboratory arm (29%)." The Company estimates that an additional c. 4,200 stroke patients benefitting from alternative prescribing decisions could be identified annually using the Genedrive CYP2C19 ID Kit due to its increased target coverage and ethnic inclusivity. Test results impacted prescription practices, guiding prescription changes and aligning treatment with patients' genetic profiles for better outcomes. Notably, 100% of patients in the genedrive PoC arm requiring clopidogrel prescription had their results available whilst on-ward, whereas 88% of patients in the laboratory arm had been discharged (requiring follow-up activities for prescription change activities). Genedrive®? CY P2C19 ID kit "test failure rate of 0.49%, in the acute clinical setting. Implementation of Genedrive®? CYp2C19 testing was feasible, scalable and effective in providing immediate availability of results during acute clinical settings. Moreover, the findings substantiate the clinical utility of CYP2C19 Genotype-guided antiplatelet therapy in the management of patients with ischemic stroke or TIA, particularly with diverse British and European populations. Rapid availability of test results enables actionable prescription choices and reduces the risk of less effective medications being prescribed for secondary prevention of stroke. CYP2C19 interventional testing is estimated to offer PS160M of value annually to the UK NHS, with rapid CYP2C19 testing estimated to release 62,500 bed days and 235,000 healthcare professional hours annually and aligns perfectly with NHS 10-year plan ambitions for realising the patient and financial benefits of shifting spending to prevention from treatment.
お知らせ • Nov 27Genedrive plc Announces Nhs Implementation Guide Published for Cyp2c19 Genotype Testinggenedrive plc notes the publication of the "NHS implementation guide for CYP2C19 genotype testing to guide Clopidogrel use after ischaemic stroke ("IS") or transient ischaemic attack ("TIA") to support prescribing decisions in stroke. Following the National Institute for Health and Care Excellence ("NICE") recommendation for CYP2C19 Genotypeing in TIA and IS including the Genedrive®? CYP2C19 ID Kit as the preferred rapid testing platform, and a national pilot implementing both laboratory and "rapid testing" approaches, the implementation guide encourages stroke services to use the guide to plan how CYP2C19 genotyping could be integrated locally. Interim presentation of the pilot results highlighted that the vast majority of stroke patients had moved further down the care pathway by the time results were available from laboratory testing (which takes several days to weeks), whereas actionable results were available from rapid testing within just over one hour. The guide notes that; Patients at hyperacute stroke units typically have a short length of stay, which may be more suitable for rapid testing. In the context of TIA and non-disabling stroke, clopidogrel is typically started immediately. Turnaround time of laboratory testing means patients may require an additional appointment to change their prescription. This group of patients may be receiving less effective secondary prevention for the days between the test and until an alternative medicine is started. Rapid testing may reduce the need for follow-up appointments or additional communication to other services to action a prescribing decision.
お知らせ • Nov 26genedrive plc Announces Scotland National Roll-Out of Genedrive MT-RNR1 ID Kitgenedrive plc note the recent media coverage of its Genedrive MT-RNR1 ID Kit, which reduces the risk of deafness in newborn babies and introduced initially by NHS Greater Glasgow and Clyde. The Genedrive MT-R NR1 ID Kit will start being used for babies requiring antibiotic treatment for infections within the Neonatal Intensive Care Unit at the Royal Hospital for Children ("RHC") in Glasgow, with the Royal Alexandra Hospital and Princess Royal Maternity Hospital to follow soon after, as part of a phased rollout to all NHS Scotland Health Boards with neonatal units over the coming months.
お知らせ • Sep 25+ 1 more updategenedrive plc has completed a Follow-on Equity Offering in the amount of £3.1975 million.genedrive plc has completed a Follow-on Equity Offering in the amount of £3.1975 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 400,000,000 Price\Range: £0.002 Security Features: Attached Warrants Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 1,198,750,000 Price\Range: £0.002 Security Features: Attached Warrants Transaction Features: Subsequent Direct Listing
お知らせ • Sep 24genedrive plc has filed a Follow-on Equity Offering in the amount of £0.3 million.genedrive plc has filed a Follow-on Equity Offering in the amount of £0.3 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 150,000,000 Price\Range: £0.002 Security Features: Attached Warrants
お知らせ • Aug 21genedrive plc Announces the Genedrive MT-RNR1 ID Kit Is Being Introduces by NHS Greater Glasgow and Clydegenedrive plc announced that the Genedrive MT-RNR1 ID Kit, which reduces the risk of deafness in newborn babies is being introduced by NHS Greater Glasgow and Clyde in September 2025 as part of the national rollout funded by the Scottish Government ("Genetic test to prevent hearing loss in newborns to begin national rollout in NHS Greater Glasgow and Clyde - NHSGGC). The Genedrive MT-R NR1 ID Kit will start being used for babies requiring antibiotic treatment for infections within the Neonatal Intensive Care Unit at the Royal Hospital for Children ("RHC") in Glasgow next month, with the Royal Alexandra Hospital and Princess Royal Maternity Hospital to follow soon after. It will be rolled out to all territorial health boards with neonatal units over the next 18 months. The initiative follows an assessment by the Chief Scientist Office funded Accelerated National Innovation Adoption ("ANIA") pathway, led by the Centre for Sustainable Delivery ("CfSD"), and a Programme for Government commitment from the Scottish Government to provide PS0.8 million to support national adoption. It follows the ongoing UK-wide PALOH (Pharmacogenetics to Avoid Loss of Hearing) programme and assessment by the Scottish Health Technologies Group. Scotland's Public Health Minister Jenni Minto visited the RHC neonatal unit to meet clinicians and representatives from the West of Scotland Innovation Hub ("WoSIH"), who have played a leading role in bringing the innovation to Scotland. Ms Minto also discussed the planned national rollout with members of the CfSD and once fully implemented, it is anticipated that more than 3,000 newborn babies would be tested during the first year. Dr Helen McDevitt, Consultant Neonatologist with NHSGGC and clinical lead for the PALOH-UK study at the RHC, said: "The introduction of this point-of-care genetic testing for newborn babies requiring antibiotic treatment for bacterial infection is a landmark moment for neonatal care in Scotland. By introducing this test, the Company is at the forefront of Point of Care pharmacogenetic testing in emergency healthcare. Pharmacogenetics informs on how individual genetics impact a medicines ability to work for you. Therefore, by using pharmacogenetics, medicine choices can be personalised, made safer and more effective. The Company has launched its two products, the Genedrive MT- RHC MT-RNR1 ID kit and the Genedrive CYP2C19 ID Kit, both developed and validated in collaboration with NHS partners and deployed on its point of care thermocycler platform. Both tests are single-use disposable cartridges which are ambient temperature stable, circumventing the requirement for cold chain logistics. The Directors believe the Genedrive MT-MNR1 ID Kit is a worlds-first and allows clinicians to make a decision on antibiotic use in neonatal intensive care units within 26 minutes, ensuring vital care is delivered, avoiding adverse effects potentially otherwise encountered and with no negative impact on the patient care pathway. Its CYP2C19ID Kit is a world-first and allows clinicians to making a decision on antibiotic use in Neonatal intensive care units within 26 days, ensuring vital care is delivered. Its CYP2C 19 ID Kit is delivered, avoiding adverse effects potential otherwise encountered and with no negative impacts on the patient care pathway. its CYP2C19 ID kit is expected to provide PS0.8m to support national adoption.
お知らせ • Aug 13Genedrive plc Provides Earnings Guidance for the Year Ending June 30, 2025genedrive plc provided earnings guidance for the year ending June 30, 2025. For the period, the company expects a doubling of total income of circa. £1 million (FY24: £0.5 million), driven by increased sales momentum in half year 2025 which saw income of £0.65 million (Fist half of 2025 £0.35 million). The Company's overheads in 2025 remained in line with the prior year however with a strategic shift towards focussed commercial activities.
お知らせ • May 30genedrive CYP2C19 ID Kit Receives CE-Certification Under the European in Vitro Diagnostics Regulationgenedrive plc announced the successful certification of its rapid CYP2C19 ID Kit genotyping platform under the European In Vitro Diagnostic Regulation ("IVDR") 2017/746. The IVDR replaces the In Vitro Diagnostic Directive ("IVDD") and is the current required regulatory basis for placing on the market, making available and putting into service any new In Vitro diagnostic medical devices within the European Union, with CE-IVD certification recognised for facilitating registration in several non-European countries. Approximately 30% of individuals, and up to 56% in certain ethnic groups, carry DNA variants in the CYP2C19 gene which result in sub-optimal activity of the antiplatelet drug Clopidogrel, commonly prescribed in patients with serious cardiovascular events such as Ischaemic Stroke ("IS"), Transient Ischaemic Attack ("TIA") and Acute Coronary Syndrome, where patients with these variants who are prescribed Clopidogrel typically experiencing worse outcomes. The Genedrive® CYP2C19 ID Kit identifies five of these DNA variants, some of which are particularly important in certain ethnicities. It enables rapid identification of patients who are unlikely to respond to Clopidogrel, in time-critical emergency healthcare settings where rapid appropriate antiplatelet prescription is crucial. The Genedrive® CYP2C19 ID Kit rapid test is best in class, recommended by the National Institute for Health and Care Excellence ("NICE") as the rapid genotyping platform of choice for use in the NHS, with dominant health economics, wider patient group coverage, and performance shown to be superior to laboratory testing methods.
お知らせ • May 05genedrive plc Announces CYP2C19 ID Kit CE-IVD Certification Updategenedrive plc announces that the Notified Body responsible for its certification under the European In Vitro Diagnostic Regulation (IVDR 2017/746) has informed the Company that whilst expedited significantly, the review and subsequent independent certification process of the Genedrive® CYP2C19 ID Kit has been delayed by approximately one month.
お知らせ • Apr 01genedrive plc has completed a Follow-on Equity Offering in the amount of £0.226309 million.genedrive plc has completed a Follow-on Equity Offering in the amount of £0.226309 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 15,087,261 Price\Range: £0.015
お知らせ • Mar 28genedrive plc has filed a Follow-on Equity Offering.genedrive plc has filed a Follow-on Equity Offering. Security Name: Ordinary Shares Security Type: Common Stock Price\Range: £0.015
お知らせ • Mar 27genedrive plc has filed a Follow-on Equity Offering in the amount of £1 million.genedrive plc has filed a Follow-on Equity Offering in the amount of £1 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 66,666,666 Price\Range: £0.015
お知らせ • Dec 07genedrive plc, Annual General Meeting, Dec 30, 2024genedrive plc, Annual General Meeting, Dec 30, 2024. Location: the incubator building, grafton street, m13 9xx, manchester United Kingdom
お知らせ • Nov 22genedrive plc to Report Fiscal Year 2024 Results on Nov 29, 2024genedrive plc announced that they will report fiscal year 2024 results at 8:00 AM, GMT Standard Time on Nov 29, 2024
お知らせ • Nov 21genedrive plc Announces Successful Funding Award to Its Clinical Partners from the National Institute for Health and Care Research in Collaboration with the UK Government Office for Life Sciencesgenedrive plc announced a successful funding award to its clinical partners from the National Institute for Health and Care Research (NIHR) in collaboration with the UK Government Office for Life Sciences (OLS) to address evidence generation requirements of the National Institute for Health and Care Excellence ("NICE") Early Value Assessment ("EVA") for the Genedrive® MT-RNR1 ID kit. The NIHR/OLS Real World Evidence Programme is aimed specifically at technologies like the Genedrive® MT-RNR1 ID kit which have been recommended for use in the NHS via the NICE EVA, to enable the addressing of real-world evidence gaps and the potential subsequent provision of a full (non-conditional) recommendation by NICE to accelerate the widespread adoption and implementation into the NHS. The programme is clinician consortia-based and will be led by principal investigators Professor Bill Newman and Dr. John McDermott (University of Manchester /Manchester University NHS Foundation Trust), with 14 separate hospital Neonatal Intensive Care Units across England (inclusive of some sites which have already implemented the Genedrive® MT-RNR1 ID test as part of routine clinical use), Scotland, Wales and Northern Ireland (inclusive of nine sites already utilising the Genedrive® MT-RNR1 ID test in routine clinical practice). The start date was 1 November 2024 with a maximum duration of 18 months, with sites phased into group 1 (sites already currently using the test) and group 2 (remaining sites). Group 1 site testing is funded under the programme for six months from project initiation, following which funding for continuity of routine clinical practice will be required to be sought from alternative sources by those sites. Revenue to Genedrive for the MT-RNR1 ID kit under the programme is expected to be approximately £500,000. Whilst scheduled for a maximum of 18 months, performance data can be submitted to the NICE EVA Evidence Generation team at an earlier point if the team believes the evidence generation requirements have been successfully fulfilled. Performance data generated during the programme is also expected to contribute towards clinical performance data requirements for FDA as part of planned De novo submission process required for commercial entry into the U.S.
New Risk • Oct 14New minor risk - Financial data availabilityThe company's latest financial reports are more than 6 months old. Last reported fiscal period ended December 2023. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (68% average daily change). Shareholders have been substantially diluted in the past year (416% increase in shares outstanding). Revenue is less than US$1m (UK£272k revenue, or US$355k). Minor Risks Latest financial reports are more than 6 months old (reported December 2023 fiscal period end). Market cap is less than US$100m (€16.2m market cap, or US$17.7m).
お知らせ • Aug 06Genedrive plc Announces CEO Changesgenedrive plc announced that its Chief Executive Officer ("CEO"), James Cheek, has left the Company with immediate effect by mutual agreement. James has been succeeded as CEO by Dr. Gino Miele PhD, currently Chief Scientific Officer ("CSO") who has been with the Company since 2011, serving as R&D Director and since September 2023 as CSO and an Executive Board Director. Prior to joining the Company Gino served as an Associate Director for clinical translational genomics at Wyeth and Pfizer. Gino has been a key driver in the development of the genedrive instrumentation and products, positioning the Company at the forefront of pharmacogenomic testing in emergency healthcare settings and with the wider team has facilitated regulatory approval processes for the products throughout the UK, Europe and the Middle East. Gino was instrumental in the NICE approval processes for both the Genedrive® MT-RNR1 ID Kit and the Genedrive® CYP2C19 ID Kit, securing the Group's clinical trial agreement in the U.S., the recent FDA breakthrough device designation, and together with the genedrive commercial team is actively involved in generating a growing list of revenue opportunities in the UK and more widely.
お知らせ • Jul 15Genedrive plc Receives Breakthrough Device Designation from the U.S. Food and Drug Administrationgenedrive plc announced that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration for the Genedrive® MT-RNR1 ID Kit. The Genedrive® MT-RNR1 kit is the world's first rapid point-of-care test to screen infants in an urgent care setting for a genetic variant that can cause life-long hearing loss when carriers of the variant are given certain antibiotics. Those infants identified by the Genedrive® MT-RNR1 ID kit as carrying the variant can then be given alternative antibiotics. It has the potential to save thousands of children from lifelong hearing loss, whilst providing a net positive financial outcome case to healthcare systems. The Breakthrough Devices Program1 is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorisation. Breakthrough Devices must meet the FDA's standards for device safety and effectiveness in order to be authorised for marketing. Devices subject to premarket approval applications ("PMA"), premarket notification 510(k), or requests for De Novo classification request are eligible for Breakthrough Device Designation if the device meets FDA criteria that it "provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions", in addition to "there being No Approved or Cleared Alternatives" and "Device Availability being in the Best Interest of Patients". The Breakthrough Devices Program offers manufacturers an opportunity to interact with FDA experts through several different programme options to efficiently address topics as they arise during the premarket review phase. This interaction can help manufacturers receive feedback from the FDA and identify areas of agreement in a timely way. Manufacturers can also expect prioritised review of their submission In 2021, 3.7 million babies were born in the USA, with 10.5% born prematurely. It was estimated that malpractice litigation settlements in cases related to deafness caused by the use of aminoglycosides average over US$1.1 million per case, further adding to the positive health economic case of providing accurate and timely testing to reduce unwanted side effects of gentamicin usage. Extrapolating from UK figures, the Company estimates that approximately 1,000 babies per annum in U.S. Neonatal Intensive Care Units ("NICU") are at risk of aminoglycoside induced hearing loss. Genedrive intends to pursue the FDADe Novoregulatory pathway for entry into the U.S. market. The FDA De Novo pathway provides a vehicle for establishing new predicate devices that can reflect modern standards for performance and safety and can serve as a basis for future clearances. De Novo classification is a risk-based classification process used when there is a lack of a predicate device already cleared by the FDA.
お知らせ • May 31genedrive plc has completed a Follow-on Equity Offering in the amount of £6 million.genedrive plc has completed a Follow-on Equity Offering in the amount of £6 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 138,799,994 Price\Range: £0.015 Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 135,177,430 Price\Range: £0.015 Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 126,022,576 Price\Range: £0.015 Transaction Features: Regulation S; Rights Offering; Subsequent Direct Listing
お知らせ • May 11genedrive plc has filed a Follow-on Equity Offering in the amount of £3.5 million.genedrive plc has filed a Follow-on Equity Offering in the amount of £3.5 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 233,333,333 Price\Range: £0.015 Transaction Features: Regulation S
New Risk • Apr 06New major risk - Shareholder dilutionThe company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 55% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-UK£3.9m free cash flow). Share price has been highly volatile over the past 3 months (83% average weekly change). Shareholders have been substantially diluted in the past year (55% increase in shares outstanding). Revenue is less than US$1m (UK£272k revenue, or US$344k). Minor Risk Market cap is less than US$100m (€10.6m market cap, or US$11.5m).
お知らせ • Mar 16genedrive plc to Report First Half, 2024 Results on Mar 28, 2024genedrive plc announced that they will report first half, 2024 results on Mar 28, 2024
New Risk • Feb 07New major risk - Market cap sizeThe company's market capitalization is less than US$10m. Market cap: €9.25m (US$9.94m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-UK£3.9m free cash flow). Share price has been highly volatile over the past 3 months (57% average daily change). Revenue is less than US$1m (UK£55k revenue, or US$69k). Market cap is less than US$10m (€9.25m market cap, or US$9.94m). Minor Risk Shareholders have been diluted in the past year (45% increase in shares outstanding).
お知らせ • Dec 07genedrive plc, Annual General Meeting, Dec 29, 2023genedrive plc, Annual General Meeting, Dec 29, 2023, at 10:00 Coordinated Universal Time. Location: 46-48 Grafton Street Manchester United Kingdom
Reported Earnings • Dec 01Full year 2023 earnings released: UK£0.055 loss per share (vs UK£0.055 loss in FY 2022)Full year 2023 results: UK£0.055 loss per share (in line with FY 2022). Net loss: UK£5.15m (loss widened 10% from FY 2022).
New Risk • Nov 21New major risk - Market cap sizeThe company's market capitalization is less than US$10m. Market cap: €9.15m (US$9.99m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (22% average weekly change). Revenue is less than US$1m (UK£68k revenue, or US$85k). Market cap is less than US$10m (€9.15m market cap, or US$9.99m). Minor Risks Latest financial reports are more than 6 months old (reported December 2022 fiscal period end). Shareholders have been diluted in the past year (17% increase in shares outstanding).
お知らせ • Nov 17genedrive plc to Report Fiscal Year 2023 Results on Nov 30, 2023genedrive plc announced that they will report fiscal year 2023 results on Nov 30, 2023
New Risk • Oct 18New minor risk - Financial data availabilityThe company's latest financial reports are more than 6 months old. Last reported fiscal period ended December 2022. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (20% average weekly change). Revenue is less than US$1m (UK£68k revenue, or US$83k). Minor Risks Latest financial reports are more than 6 months old (reported December 2022 fiscal period end). Shareholders have been diluted in the past year (14% increase in shares outstanding). Market cap is less than US$100m (€11.7m market cap, or US$12.3m).
お知らせ • Sep 12genedrive plc Announces Chief Executive Officer Changesgenedrive plc announced the appointment of James Cheek as Chief Executive Officer of the Company. James will take up the positions and will succeed David Budd, who has notifiecd the Company of his intention to step down from the role with immediate effect. James brings extensive commercial and operational experience at a senior level through a successful career with established diagnostic companies such as Cepheid, Beckman Coulter, and Roche Diagnostics, as well as serving as an executive board member of the British In Vitro Diagnostics Association (BIVDA). The Board believes James' experience, especially his extensive involvement in selling into the NHS, will be valuable as the Company expands its commercial footprint and opportunities within the UK and more widely.
お知らせ • Sep 06Genedrive plc Achieves UKCA Marking Registration for its New Genedrive CYP2C19 Systemgenedrive plc announced it has achieved UKCA marking registration for its new Genedrive CYP2C19 System. It is a point of care pharmacogenomic test that can differentiate between patients that could respond to clopidogrel treatment and those that will not, allowing more effective drug treatment to be prescribed on a personalised basis. The test can be performed at the bedside or in a ward, and can deliver a clinically actionable result in about one hour. Poor response to treatment following stroke is common, effecting up to 30% of patients in the general population and in a recent report up to 50% in certain ethnic groups. In the UK, the National Institute for Health and Care Excellence ("NICE") recommended in May 2023 draft guidance that people who have had an ischaemic stroke or transient ischaemic attack ("TIA") should have a CYP2C19 genetic test prior to treatment. It's estimated that there are over 60 million ischaemic strokes per year globally and over 100,000 in the UK each year. The Genedrive®? CYP2C19 test uses a single, non-invasive cheek swab sample, and rapidly identifies six important genetic variants of the CYP2C19 gene, which are instrumental in the loss of metabolism function and poor activation of clopidogrel in a patient. The Genedrive System automatically interprets the information for the clinician, allowing prompt administration of an optimised treatment plan. Like all genedrive products, the tests are presented in a temperature stable, freeze-dried format, allowing testing to be performed by healthcare workers, away from laboratory locations. In its performance evaluations, the test achieved 99% accuracy in detecting the variants that underpin loss of metabolism function. UKCA marking now allows the Company to begin commercialisation in the UK, and actively engage in the DEVOTE programme (previously announced in May 2023), which will generate additional performance data in an acute care setting. This expanded dataset is required for CE marking submission, which will allow for commercialisation in the EU. Submission is expected in the first half of 2024 once genedrive's engagement with DEVOTE has completed. In the United Kingdom, the Company will be selling the product through its direct sales team, and momentum for adoption is expected to be influenced by positive final NICE recommendations for CYP2C19 testing, which are expected in December 2023.
お知らせ • Dec 06genedrive plc, Annual General Meeting, Dec 29, 2022genedrive plc, Annual General Meeting, Dec 29, 2022, at 11:00 Coordinated Universal Time. Location: 46 Grafton Street, Manchester M13 9XX Manachester United Kingdom
Reported Earnings • Nov 22Full year 2022 earnings released: UK£0.055 loss per share (vs UK£0.012 loss in FY 2021)Full year 2022 results: UK£0.055 loss per share (further deteriorated from UK£0.012 loss in FY 2021). Net loss: UK£4.68m (loss widened UK£3.98m from FY 2021).
お知らせ • Nov 14genedrive plc to Report Fiscal Year 2022 Results on Nov 21, 2022genedrive plc announced that they will report fiscal year 2022 results on Nov 21, 2022
お知らせ • Oct 06genedrive plc Files US FDA Pre-Submission for the Genedrive® MT-RNR1 Product Rangegenedrive plc announced that it has commenced engagement with the U.S. Food and Drug Administration ("FDA") to progress the regulatory approval of the Genedrive® MT-RNR1 ID Kit into the USA. The Genedrive® MT-RNR1 assay is the world's first rapid point-of-care test to screen infants in an urgent care setting for a genetic variant that will cause life-long hearing loss when carriers of the variant are given certain antibiotics. Those that carry the variant can then be given alternative treatments following detection of the variant by the Genedrive® MT-RNR1 test. It has the potential to save thousands of children from lifelong hearing loss, whilst providing a net positive financial outcome case to healthcare systems. genedrive has submitted via the FDA's Pre-Submission process because there is no exact comparable test in the market already. The Pre-Sub process allows the Company an opportunity to clarify its testing and validation approach, confirm the appropriate regulatory application pathway (510(k) vs De Novo application) and gain additional procedural feedback from the FDA with the aim of making the final submission process more efficient. In 2021, 3.7 million babies were born in the USA, with 10.5% born prematurely. It was estimated that malpractice litigation settlements in cases related to deafness caused by the use of aminoglycosides average over USD 1.1 million per case, further adding to the positive health economic case of providing accurate and timely testing to reduce unwanted side effects of gentamicin usage.
お知らせ • Aug 22Genedrive plc Announces UK's National Institute for Health and Clinical Excellence Commences an Evaluation of CYP2C19 Genotype Testing for Clopidogrel Treatmentgenedrive plc announced that the UK's National Institute for Health and Clinical Excellence has commenced an evaluation of CYP2C19 genotype testing for Clopidogrel treatment, via a new NICE Diagnostics Assessment Programme. Genedrive's CYP2C19 ID Kit, currently in development, has been included in the assessment. Both of genedrive's new emergency Point of Care genetic screening tests are now included in new NICE reviews, following the MT-RNR1 DAP announcement on 16 June 2022. Clopidogrel is a drug that is given to ischemic stroke patients to prevent further clot formation. The CYP2C19 gene is involved in a metabolic pathway in the liver that converts Clopidogrel to its active form. Clopidogrel is less effective in individuals with certain genetic CYP2C19 variants because they do not metabolize Clopidogrel fully. As a consequence, it has a reduced impact on lowering the risk of a further stroke. Genedrive's CYP2C19 ID Kit, can provide guidance on which patients will respond to Clopidogrel. Patients with gene variants that result in reduced or loss of function of CYP2C19 can be given alternative treatments. The Genedrive® CYP2C19 test is a simple, rapid point of care test, with no requirement for result interpretation and provides results in a clinically actionable timeframe. The genedrive test has been designed to have extended coverage across ethnic populations, which is important because the frequency of the various CYP2C19 related genetic changes differs across ethnicities. DAP evaluations are designed to provide robust recommendations on the use of new products, which is presented in the form of NICE guidance, and to promote rapid and consistent adoption of clinically innovative and cost-effective diagnostic technologies in the NHS. The DAP will assess the clinical and cost-effectiveness of Clopidogrel genotype testing, including any advantages of point of care testing vs central lab-based testing, in order to make recommendations on its use in the NHS. The international CPIC guideline for Clopidogrel and CYP2C19 was recently updated (January 2022). The guidelines are based on clinical evidence and peer-reviewed literature. The clinical landscape for genetically guided anti-platelet therapy can be considered to be at a more advanced stage compared to many other genetic areas. Genedrive's new CYP2C19 Kit is targeted for completion in First Quarter 2023 and will require approval under the new IVDR regulations.
お知らせ • Jun 16NICE to Evaluate the Genedrive MT-RNR1 Testgenedrive plc announced that the UK's National Institute for Health and Clinical Excellence ('NICE') has started an evaluation of the Genedrive® MT-RNR1 test via their Diagnostics Assessment Programme ('DAP'). DAP evaluations are designed to provide robust recommendations on the use of new products, which is presented in the form of NICE guidance, and to promote rapid and consistent adoption of clinically innovative and cost-effective diagnostic technologies in the NHS. An independent advisory committee considers the evidence provided, makes draft recommendations for public consultation and ultimately makes final recommendations for publication in NICE guidance. The guidance produced is used by NHS commissioners, practitioners, healthcare operational managers and purchasing and procurement organisations. genedrive's assay is the world's first rapid point of care test to screen infants in an urgent care setting for a genetic variant that will cause life-long hearing loss when carriers of the variant are given certain antibiotics. Those that carry the variant can then be given alternative treatments following detection of the variant by the Genedrive® MT-RNR1 test.
Board Change • May 31High number of new directorsChief Financial Officer & Director Russ Shaw was the last director to join the board, commencing their role in 2022.
お知らせ • May 31Genedrive plc Announces Point-Of-Care Cov19-Id Kit Receives CTDA Approval from Medicines and Healthcare Products Regulatory Agencygenedrive plc announces that the UK Medicines and Healthcare Products Regulatory Agency has granted a CTDA enabling the sale of the Genedrive® COV19-ID Kit in the United Kingdom. Genedrive's application for approval, under the requirements that came into force on 28 July 2021 via The Medical Devices (Coronavirus Test Device Approvals Regulations (2021)), was made on 21 December 2021. Since submission for approval, the product has undergone positive external validation, commercial partners have been engaged in specific countries, and product claims have been expanded to include the testing of asymptomatic patients. The Genedrive® COV19-ID Kit is a rapid molecular diagnostic test that delivers positive results as quickly as 7.5 minutes and negative results at 17 minutes. It utilises Reverse-Transcription Loop Mediated Isothermal Amplification (RT-LAMP) and a proprietary buffer formulation to achieve rapid results without requirement for user viral extraction steps. Performed directly from a mid-turbinate nasal swab, the assay targets the ORF1ab and N genes of the SARS-CoV-2 genome, adding robustness against emerging SARS-CoV-2 variants.
Board Change • Apr 27High number of new directorsChief Financial Officer & Director Russ Shaw was the last director to join the board, commencing their role in 2022.
Buying Opportunity • Apr 06Now 24% undervaluedOver the last 90 days, the stock is up 3.8%. The fair value is estimated to be €0.50, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has declined by 55% over the last 3 years. Earnings per share has grown by 26%.
Reported Earnings • Mar 30First half 2022 earnings releasedFirst half 2022 results: Net income: (down UK£991.0k from profit in 1H 2021).
お知らせ • Mar 30Genedrive plc Announces NICE issues Medtech Innovation Briefing on Genedrive ® MT-RNR1 Testgenedrive plc announced that the UK's National Institute of Clinical Excellence (NICE) has issued a new Medtech Innovation Briefing (MIB) on the Genedrive® MT-RNR1 test. genedrive's assay is the world's first point of care test to screen infants in an urgent care setting for a genetic variant that will cause life-long hearing loss when carriers of the variant are given certain antibiotics. Those that carry the variant can then be given alternative treatments following detection of the variant by the Genedrive® MT-RNR1 test. The Medtech Innovation Briefing is an important step to increase awareness in the NHS of new innovation and ultimately support adoption in the UK.
お知らせ • Mar 03genedrive plc Announces Resignation of Matthew Fowler as Group's Chief Financial Officergenedrive plc announced that Matthew Fowler, the group's chief financial officer, will be leaving the company and stepping down from the board on April 19, 2022. This follows the announcement on November 16, 2021 that Matthew Fowler intended to stand down after five years in the role, in order to take up a position as chief financial officer of musicMagpie plc.
お知らせ • Feb 24Genedrive plc Provides Update on Point of Care Covid Testgenedrive plc provides an update on the progress being made on the Genedrive®?COV19-ID kit, its rapid point of care molecular test for Covid-19. The Genedrive® COV19-ID kit is a rapid molecular diagnostic test that delivers positive results as quickly as 7.5 minutes and negative results at 17 minutes. It utilises Reverse-Transcription Loop Mediated Isothermal Amplification (RT-LAMP) and a proprietary buffer formulation to achieve rapid results without viral extraction. Performed directly from a mid-turbinate nasal swab, the assay targets the ORF1ab and N genes of the SARS-CoV-2 genome, adding robustness against emerging SARS-CoV-2 variants. The product was CE marked on 8 December 2021 and was subsequently sent for evaluation purposes to interested parties. The Company has now entered into distribution agreements covering Spain, Portugal, Oman and the United Arab Emirates, with other opportunities continuing to be assessed in other EU countries. The customer base that distributors are targeting is consistent with those that the Company has previously announced, including pharmacies, sports and private workplaces. Market requirements differ from country to country depending on government policies and legislation. These initial distributor arrangements are designed to both access and assess the longer-term market potential in each country. The Company also has end-user product evaluation ongoing in the United Kingdom to access specific occupational health markets. The product cannot be commercially sold yet in the UK, as CTDA approval is still pending. With UK government statutory requirements for COVID testing changing rapidly, future opportunities would be discretionary testing vs government mandates. The Company will continue with its commercial steps to build its sales pipeline and grow revenues and will provide updates as appropriate both on sales and material new distributor engagements.
お知らせ • Feb 04genedrive plc to Report First Half, 2022 Results on Mar 29, 2022genedrive plc announced that they will report first half, 2022 results on Mar 29, 2022
お知らせ • Dec 23genedrive plc Announces UK CTDA application for Point-of-Care Genedrive®?COV19-ID kitgenedrive plc further to the announcement on 29 November 2021 confirming submission for CE-IVD certification for the Genedrive® COV19-ID Kit, expanded product validation requirements have now been completed and the Company has filed for approval to sell the product in the United Kingdom under the new Coronavirus Test Device Approvals (CTDA) regulations. CTDA regulations came into effect on 1 Nov. 2021 and place specific registration, review and performance requirements on suppliers of COVID-19 diagnostic products into the United Kingdom. The expanded clinical validation sample cohort required for CTDA approval was referenced against the Thermo Fisher TaqPath COVID-19 RT-PCR test. In the 264 samples, specificity was 98%, and sensitivity was 98% in samples with viral load >500 copies per ml. This cohort included samples of confirmed Omicron variant, all of which were successfully detected. The sensitivity and specificity of the Genedrive® COV19-ID assay on the entire cohort met the current requirements of the UK's MHRA Target Product Profile for SARS-CoV-2 Point-of-Care molecular diagnostic tests. The Genedrive® COV19-ID kit is a rapid molecular diagnostic test that delivers positive results as quickly as 7.5 minutes and negative results at 17 minutes. It utilises Reverse-Transcription Loop Mediated Isothermal Amplification (RT-LAMP) and a proprietary buffer formulation to achieve rapid results without requirement for user viral extraction steps. Performed directly from a mid-turbinate nasal swab, the assay targets the ORF1ab and N genes of the SARS-CoV-2 genome, adding robustness against emerging SARS-CoV-2 variants.
Reported Earnings • Nov 10Full year 2021 earnings released: UK£0.012 loss per share (vs UK£0.55 loss in FY 2020)The company reported a decent full year result with reduced losses and improved control over expenses, although revenues were weaker. Full year 2021 results: Revenue: UK£687.0k (down 35% from FY 2020). Net loss: UK£691.0k (loss narrowed 96% from FY 2020).
Board Change • Sep 02Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 5 experienced directors. No highly experienced directors. Independent Non-Executive Director Chris Henry Yates was the last director to join the board, commencing their role in 2018. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.
お知らせ • Jul 02Genedrive COVID-19 Point of Care device updategenedrive plc provides an update on the development of its Genedrive® COV19-ID Kit, a rapid Point of Care (PoC) molecular test for SARS-CoV-2 detection, designed for the Company's Genedrive® instrument. The Company has been developing a new, best-in-class PoC molecular workflow and assay for more than 9 months. The Company is pleased to release the product's current performance specifications as it moves towards the stages of formal clinical qualification and regulatory filing. While acknowledging the longer than anticipated development time, the Company has overcome significant technical hurdles and also further improved performance specifications alongside evolving marketplace requirements. Key specifications of sensitivity, specificity, speed, ease of use, and scalability have all been improved or addressed. The Genedrive® COV19-ID Kit detects the presence of SARS-CoV-2 virus in a nasal swab. The product has been designed to provide an ease of use appropriate for people inexperienced in molecular testing. Positive samples are detected as quickly as 9-10 minutes, with a negative result reported after 20 minutes if no signal is detected. In contrast to many competitor products, the test targets two genes of the SARS-CoV-2 genome, and is shown to be inclusive of all current Variants of Concern (VoCs), including the Delta variant. The intent of a two-gene design is to provide additional robustness to new emerging VoCs in the future. The specificity of the test during design verification (30 positive and 30 negative contrived clinical samples) was 100%, with a PCR comparable limit of detection of 10-20 copies per reaction. The testing procedure does not require extraction of the virus from the patient's sample. The Company has developed a proprietary lysis buffer that is used to resuspend patient swab material, while providing biosafety to users. Exact quantification of biosafety is currently being assessed in an independent UK Public Health England laboratory. A fully biosafe process would present additional or novel opportunities and use-cases for PoC COVID-19 testing. The simple, 4-step workflow uses an 'eye-dropper' liquid transfer process familiar from lateral flow testing, and makes the system appropriate for use by those without previous molecular experience.
Reported Earnings • Mar 28First half 2021 earnings released: EPS UK£0.019 (vs UK£0.089 loss in 1H 2020)First half 2021 results: Revenue: UK£355.0k (down 43% from 1H 2020). Net income: UK£991.0k (up UK£4.03m from 1H 2020).
お知らせ • Mar 09genedrive plc Enters Distribution Agreement with Mountain Horse Solutionsgenedrive plc announced that it has entered into an agreement for the distribution of the company's military pathogen detection assays in the United States with Mountain Horse Solutions.
お知らせ • Mar 04genedrive plc Provides an Update on its Antibiotic Induced Hearing Loss Assaygenedrive plc provided an update on its Antibiotic Induced Hearing Loss (AIHL) assay. As announced on the 3 December 2020, an 11 month implementation trial at Manchester University NHS Foundation Trust and Liverpool Women's Hospital successfully concluded in November 2020. The results of the study will be published in a peer reviewed journal. The study's primary outcomes were very positive, showing genedrive's utility as the world's first rapid genetic test in an emergency care neonatal setting. In excess of 750 babies were tested and 160 hospital staff were trained to provide rapid testing in this critical care setting. Since completion of the trial, there has been new clinical guidance in the UK1on the importance of the management of specific genetic mutations and their role in hearing loss as a result of antibiotics (ototoxicity). Government and Society guidance are considered a key factor influencing the speed and extent of future adoption. The Company and Inspiration Healthcare Group plc (AIM: IHC), the distribution partner for the AIHL assay, believe this will lead to increased demand for the genedrive AIHL test in the UK. This new government guidance reminds healthcare professionals about the impact of antibiotic related ototoxicity and to consider the need for genetic testing prior to initiation of treatment. genedrive's assay is the only commercial point of care test available for the testing of MT-RNR1, the most important mutation contributing to AIHL in infants. The launch of the genedrive AIHL assay remains on track for summer 2021 and the Company is enthusiastic about both the commercial prospects and the clinical benefits of this novel test to prevent potential irreversible hearing loss and this test becoming a standard of care. The Company is executing initial stage key opinion leader engagement in the UK alongside Inspriration Healthcare in preparation for commercial launch.
Is New 90 Day High Low • Feb 07New 90-day high: €1.05The company is up 48% from its price of €0.71 on 09 November 2020. The German market is up 15% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Life Sciences industry, which is up 3.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €0.27 per share.
お知らせ • Jan 29genedrive plc Enters into Distribution Agreement with Beckman Coulter Life Sciencesgenedrive plc announced that it has entered into a distribution agreement with Beckman Coulter Life Sciences ("Beckman Coulter") for its Genedrive 96 SARS-CoV-2 Kit. The agreement enables Beckman Coulter to sell and distribute genedrive's high-throughput COVID-19 PCR Kit in the United States and Europe for use on upper respiratory viral samples. The agreement is the result of the collaboration agreement announced in August 2020, under which the companies worked to develop and validate a fully automated PCR process for Beckman Coulter's Biomek automated workstation in conjunction with its RNAdvance Viral XP extraction kit. The Genedrive 96 SARS-CoV-2 test is ideally suited for use on the high throughput robotic Biomek i7 instrument. The ready-to-go nature of the test removes many of the fluid dispensing steps required in competitor assays, increasing the overall throughput of the Biomek compared to using a liquid reagent based test formulation. Full automation of the overall PCR workflow can allow laboratories to run large numbers of tests over extended working hours or workstation platforms. Beckman Coulter estimates that this new turnkey solution could process circa 1,000 PCR samples per Biomek workstation installed during a standard 8-hour working day, using just a 0.5 full-time-equivalent in technician time for processing.
お知らせ • Jan 19genedrive plc to Report First Half, 2021 Results on Mar 25, 2021genedrive plc announced that they will report first half, 2021 results on Mar 25, 2021
Is New 90 Day High Low • Jan 14New 90-day low: €0.32The company is down 75% from its price of €1.31 on 16 October 2020. The German market is up 10.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Life Sciences industry, which is up 1.0% over the same period.
お知らせ • Jan 01genedrive plc, Annual General Meeting, Dec 30, 2020genedrive plc, Annual General Meeting, Dec 30, 2020. Agenda: To consider and receive the annual report and accounts for the company; to approve the directors remuneration report; to re-appoint Tom Lindsay as a director; to re-appoint Chris Yates as a director; to re-appoint David Budd as a director; to re-appoint Matthew Fowler as a director; to re-appoint Ian Gilham as a director; to re-appointment of RSM UK as auditors of the company; to consider directors authority to allot shares; and to consider disapplication of pre-emption rights.
Is New 90 Day High Low • Dec 12New 90-day low: €0.37The company is down 56% from its price of €0.83 on 11 September 2020. The German market is up 1.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Life Sciences industry, which is up 3.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €0.19 per share.
お知らせ • Dec 04Genedrive plc Announces Successful Completion of the Antibiotic Induced Hearing Loss Implementation StudyGenedrive plc announced the successful completion of the Antibiotic Induced Hearing Loss implementation study into the use of the genetic test in an NHS neonatal intensive care setting. The Genedrive MT-RNR1 ID Kit has been used over the past 11 months in a trial of what is thought to be a world first use of a genetic test in a neonatal intensive care setting. The Genedrive assay has been used at Manchester University NHS Foundation Trust and Liverpool Women's Hospital to screen babies before administering certain antibiotics that are known to cause deafness in infants. Over the period of the study, approximately 750 babies have been tested with the Genedrive MT-RNR1 Kit, with all valid results being confirmed by DNA sequencing. Genedrive is now working with the study team to publish the data, due in early 2021, and with Inspiration Healthcare plc to plan the roll-out for commercial use. Full launch of the product is expected from June 2021, following the inclusion of feedback from the trial sites in the product configuration.
Analyst Estimate Surprise Post Earnings • Nov 30Revenue misses expectationsRevenue missed analyst estimates by 37%. Over the next year, revenue is forecast to grow 193%, compared to a 18% growth forecast for the Life Sciences industry in Germany.
Reported Earnings • Nov 30Full year 2020 earnings released: UK£0.55 loss per shareThe company reported a poor full year result with increased losses and weaker revenues and control over expenses. Full year 2020 results: Revenue: UK£1.06m (down 55% from FY 2019). Net loss: UK£19.4m (loss widened 434% from FY 2019).
お知らせ • Nov 20Genedrive Announces HCV ID Kit Demonstrates High Clinical Accuracy in India Studygenedrive plc announces the publication of the study data for the 'Evaluation of the Point of Care Molecular Diagnostic Genedrive HCV ID Kit for the detection of HCV RNA in clinical samples. The study was led by Dr Ekta Gupta at ILBS, New Delhi, India. The objective of the study was to determine the diagnostic accuracy of the Genedrive HCV ID Kit, as a confirmatory test for seropositive hepatitis C virus (HCV) patients in Indian demographic settings. The diagnostic accuracy of the Genedrive HCV ID Kit was evaluated by comparing the test with the Abbott Real time HCV test on the lab-based Abbott m2000 platform in an Indian demographic and across a range of different genotypes, to ensure suitability for introduction of the product to the Indian population. In India the circulation of HCV genotype is predominantly genotypes 3 and 1 with live infections of HCV estimated at between 6-12 million.
Reported Earnings • Nov 19Full year 2020 earnings released: UK£0.55 loss per shareThe company reported a poor full year result with increased losses and weaker revenues and control over expenses. Full year 2020 results: Revenue: UK£1.06m (down 55% from FY 2019). Net loss: UK£19.4m (loss widened 434% from FY 2019).
Analyst Estimate Surprise Post Earnings • Nov 19Revenue misses expectationsRevenue missed analyst estimates by 37%. Over the next year, revenue is forecast to grow 315%, compared to a 17% growth forecast for the Life Sciences industry in Germany.
Is New 90 Day High Low • Nov 09New 90-day low: €0.71The company is down 19% from its price of €0.88 on 11 August 2020. The German market is down 1.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Life Sciences industry, which is up 16% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €0.21 per share.
お知らせ • Oct 29genedrive plc to Report Fiscal Year 2020 Results on Nov 17, 2020genedrive plc announced that they will report fiscal year 2020 results on Nov 17, 2020
お知らせ • Oct 04genedrive plc Announces South African Approvalgenedrive plc announced that the Company's Genedrive® 96 SARS-CoV-2 Kit has received approval from the South African Health Products Regulatory Authority. The Genedrive® kit was submitted for evaluation in June 2020. Under the approval, the Kit can now be distributed and sold within South Africa. Genedrive products are supplied in the country, and more broadly within Africa, via the Sysmex EMEA organisation. Since the original evaluation, genedrive has expanded the number of PCR platforms and RNA isolation kit providers which are validated for the Company's Kit. This is important for markets such as South Africa where high testing volumes are supported by the prevalence of automated/robotic RNA extraction instruments, and the variety of testing platforms is diverse owing to a split between public and private testing facilities.
お知らせ • Sep 26genedrive plc Announces Completes Initial Testing of Beckman Coulter Life Sciences' Rnadvance Viral RNAgenedrive plc announced that has completed initial testing of Beckman Coulter Life Sciences' RNAdvance Viral RNA extraction chemistry on respiratory swabs in conjunction with its COVID-19 PCR test. The sensitivity in using the Genedrive Kit with samples from upper respiratory swabs is equivalent to the existing Genedrive SARS-CoV-2 Kit specification claim, indicating the Beckman product is suitable for use in the Genedrive testing workflow. The Beckman RNAdvance kit has now been added to the Genedrive 96 SARS-CoV2 Instruction for Use as a validated extraction protocol for swabs. This is an important technical milestone in transitioning the Genedrive® 96 SARS-CoV-2 Kit to a fully automated workflow using Beckman's RNA extraction and Biomek automated workstation.
Is New 90 Day High Low • Sep 22New 90-day high: €1.48The company is up 16% from its price of €1.28 on 24 June 2020. The German market is up 4.0% over the last 90 days, indicating the company outperformed over that time. However, it underperformed the Life Sciences industry, which is up 22% over the same period.