Announcement • Jul 07
Verici Dx plc to Report Fiscal Year 2025 Results on Jul 08, 2026 Verici Dx plc announced that they will report fiscal year 2025 results at 8:00 AM, GMT Standard Time on Jul 08, 2026 Reported Earnings • Jun 30
Full year 2025 earnings released: US$0.90 loss per share (vs US$0.025 loss in FY 2024) Full year 2025 results: US$0.90 loss per share (further deteriorated from US$0.025 loss in FY 2024). Revenue: US$3.66m (up 9.7% from FY 2024). Net loss: US$6.93m (loss widened 18% from FY 2024). Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 36 percentage points per year, which is a significant difference in performance. Announcement • Jun 29
Verici Dx plc, Annual General Meeting, Jul 28, 2026 Verici Dx plc, Annual General Meeting, Jul 28, 2026. Location: shoosmiths llp, no 1 bow churchyard, ec4m 9dq, london United Kingdom Announcement • Jun 25
Verici Dx Receives New York State Approval for Tutivia Kidney Transplant Rejection Test Verici Dx plc received clinical laboratory accreditation from the New York State Department of Health Clinical Laboratory Evaluation Program. The Company also received New York state approval of Tutivia, its blood-based laboratory developed test that delivers predictive, data-driven intelligence in the form of an easy-to-interpret risk score classifying patients as low or high risk of acute rejection of the kidney transplant. By detecting rejection-associated biological mechanisms, the Tutivia test provides clinicians with a proactive indicator of rejection risk, enabling more precise patient management and risk stratification, better-timed interventions, and the potential to reduce avoidable biopsies and graft loss. With this New York state certification, Verici Dx is now authorized to provide laboratory testing services in all 50 U.S. states and the District of Columbia, creating nationwide availability of the Tutivia test. Tutivia combines transcriptomics with proprietary machine learning algorithm to deliver predictive intelligence for acute kidney transplant rejection. The test provides clinicians with deeper insight to support more precise immunosuppression management by distinguishing rejection from other causes of graft injury, such as BK virus–associated nephropathy and ischemia–reperfusion injury, which can confound conventional blood tests including serum creatinine and cell-free DNA. The science underlying Tutivia was pioneered at The Mount Sinai Hospital in New York. Its development is grounded in decades of clinical expertise and scientific rigor, and New York State approval represents a full-circle milestone, bringing a locally developed innovation back to the state’s transplant community with nationwide reach. The Tutivia test was validated in a clinical study that included a broad and diverse transplant patient population. Announcement • Jun 24
Verici Dx plc Receives New York State Clinical Laboratory Certification Verici Dx Plc, a developer of advanced clinical diagnostics for organ transplant, announced that it has received clinical laboratory certification from the New York State Department of Health Clinical Laboratory Evaluation Program. Having achieved New York state certification, the nation's most rigorous laboratory evaluation program, Verici Dx has now completed its full authorisation to provide laboratory testing services in all 50 US states and the District of Columbia, creating nationwide availability of the Tutivia test. The Company also received state approval for Tutivia, its blood-based laboratory developed test that delivers predictive, data-driven intelligence in the form of an easy-to-interpret risk score classifying patients as low or high risk of acute rejection of the kidney transplant. Announcement • Jun 12
Verici Dx plc has completed a Follow-on Equity Offering in the amount of AUD 0.18671 million. Verici Dx plc has completed a Follow-on Equity Offering in the amount of AUD 0.18671 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 53,345,832
Price\Range: AUD 0.0035 Announcement • Jun 10
Verici Dx plc has filed a Follow-on Equity Offering in the amount of AUD 0.2 million. Verici Dx plc has filed a Follow-on Equity Offering in the amount of AUD 0.2 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 57,142,857
Price\Range: AUD 0.0035 Board Change • May 20
Less than half of directors are independent There are 4 new directors who have joined the board in the last 3 years. Of these new board members, none were independent directors. The company's board is composed of: 4 new directors. 8 experienced directors. No highly experienced directors. 2 independent directors (3 non-independent directors). Independent Non-Executive Chairman Julian Baines is the most experienced director on the board, commencing their role in 2020. Senior Independent Non-Executive Director Ian Carruthers was the last independent director to join the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of experienced directors. Announcement • May 20
Verici Dx plc Announces Publication Validating Pre-Transplant Gene Signature Test For Predicting Early Acute Rejection In Kidney Transplant Recipients Verici Dx plc announced the publication of a peer-reviewed clinical validation study of the Pre-Transplant Rejection Assessment (PTRA) test that stratifies patients undergoing deceased donor kidney transplantation as to their risk of acute rejection in the first two months post-transplant. The study, entitled “A Pre-Kidney Transplant Blood-Based Next-Generation Sequencing Assay to Predict Early Acute Rejection” was published in Kidney360. The PTRA test is commercially marketed by Thermo Fisher Scientific. The test consists of an RNA signature comprised of 29 genes involved in oxidative stress, endothelial injury, metabolic regulation, as well as immune pathways associated with T cell– and antibody-mediated mechanisms of rejection. The test was observed in the clinical validation study to operate mostly independently of donor characteristics, focusing instead on an intrinsic, recipient-specific rejection phenotype, and demonstrates superior performance compared with standard risk features. PTRA outperformed conventional risk assessment tools, including panel reactive antibodies (PRA) in the ability to predict EAR in the first two months following transplant. Currently, kidney transplant recipients receive standardized immunosuppressive regimens, with more aggressive therapy often reserved for patients perceived as high-risk, typically based on broad criteria such as high PRA levels. However, these conventional risk features have limited predictive value, which can lead to unnecessary over-suppression and risks related to toxicity, infections and malignancy. Despite decades of progress in transplant medicine, clinicians still rely largely on broad, population-based risk markers that lack the precision needed to guide more individualized care. As a result, immunosuppressive strategies have remained largely one-size-fits-all for more than a decade. The Pre-Transplant Rejection Assessment (PTRA) test is a laboratory developed test that is used for clinical purposes by the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the U.S. Food and Drug Administration (FDA) or CE marked in the EU as an in vitro diagnostic test. Announcement • Apr 18
Verici Dx plc Appoints Keith Gilliard as Senior Director of Sales Verici Dx plc announced that Keith Gilliard was also appointed as Senior Director of Sales to lead the sales team, in a non-Board position. Keith has previously held senior sales roles at Waters Medical Systems, OrganOx Inc., CareDx Inc., Bristol-Myers Squibb and Novartis Pharmaceuticals. Announcement • Oct 08
Verici Dx plc Announces Board Changes, Effective October 6, 2025 Verici Dx plc announced the appointment to the Board of Aubrey Powell, as Non-executive Director, with immediate effect. At the same time, Dr Erik Lium, Non-executive Director since August 2020 and representative of Mount Sinai on the Board, will step down from the Board with immediate effect. Aubrey has over 30 years' experience in supporting and advising growth companies, 26 of which have been spent in investment banking and corporate finance. He trained at Salomon Brothers (now Citi) for two years before transitioning to small and mid-cap roles at Panmure Gordon where he spent 12 years (including buyside investment and portfolio company support, as well as early-stage public companies at Durlacher prior to Panmure Gordon's reverse takeover in April 2005). Aubrey worked at N+1 Singer, which became Singer Capital Markets, from early 2012 to mid-2024, serving as an AIM Qualified Executive and advising Main Market companies, as Sponsor, on their obligations. Aubrey has extensive experience in deal execution in equity capital markets and M&A, for public companies as well as private, and has focused predominantly on Healthcare and Life Sciences, TMT and other technology-enabled businesses, over the course of his career. He brings a blend of skills from corporate finance to deal-making, as well as a strong track record of effectively guiding clients through reporting cycles, which supports his proposed role as a member of the Audit Committee, as well as advising on their wider regulatory and investor obligations including corporate governance. Previous experience also includes strategic consultancy covering growth and investment decision-making, as well as corporate communications, and working in biotech research for ICI Pharmaceuticals. In accordance with AIM Rule 17 and Schedule 2(g) of the AIM Rules, Aubrey Richard Powell (aged 54) currently holds the following directorship: Aubrey Powell Consulting (APC) Limited. Previous directorships or partnerships of which the director has been a director or partner over the last five years: Apus Sequestration LLP and Maia Green LLP. Mr. Powell holds no shares in the Company. Announcement • Jul 29
Verici Dx plc has completed a Follow-on Equity Offering in the amount of £0.431434 million. Verici Dx plc has completed a Follow-on Equity Offering in the amount of £0.431434 million.
Security Name: Ordinary shares
Security Type: Common Stock
Securities Offered: 86,286,792
Price\Range: £0.005 Announcement • Jul 21
Verici Dx plc has filed a Follow-on Equity Offering in the amount of £5.037195 million. Verici Dx plc has filed a Follow-on Equity Offering in the amount of £5.037195 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 1,000,000,000
Price\Range: £0.005
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 7,439,092
Price\Range: £0.005
Transaction Features: Regulation S; Subsequent Direct Listing Announcement • Jun 30
Verici Dx plc, Annual General Meeting, Jul 29, 2025 Verici Dx plc, Annual General Meeting, Jul 29, 2025. Location: shoosmiths llp, no 1 bow churchyard, ec4m 9dq, london United Kingdom Announcement • Apr 08
Verici Dx plc Provides Earnings Guidance for the Year 2024 Verici Dx plc provided earnings guidance for the year 2024. For the year, the company expected to report full year revenues of $3.3 million. New Risk • Nov 13
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: €8.75m (US$9.24m) 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 Risk Market cap is less than US$10m (€8.75m market cap, or US$9.24m). Minor Risks Share price has been volatile over the past 3 months (9.3% average weekly change). Shareholders have been diluted in the past year (42% increase in shares outstanding). Revenue is less than US$5m (US$4.3m revenue). Board Change • Sep 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 12 experienced directors. No highly experienced directors. Non-Executive Director & Chair of Science Advisory Board Lorenzo Gallon was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Announcement • Jul 12
Verici Dx plc to Report Q2, 2024 Results on Jul 15, 2024 Verici Dx plc announced that they will report Q2, 2024 results on Jul 15, 2024 Announcement • Jun 08
Verici Dx plc, Annual General Meeting, Jun 25, 2024 Verici Dx plc, Annual General Meeting, Jun 25, 2024. Location: shoosmiths llp, no 1 bow churchyard, ec4m 9dq, london United Kingdom New Risk • Feb 29
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 42% This is considered a minor 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 Risk Revenue is less than US$1m (US$19k revenue). Minor Risks Share price has been volatile over the past 3 months (9.5% average weekly change). Shareholders have been diluted in the past year (42% increase in shares outstanding). Market cap is less than US$100m (€32.6m market cap, or US$35.3m). Announcement • Feb 14
Verici Dx plc has completed a Follow-on Equity Offering in the amount of £6.5 million. Verici Dx plc has completed a Follow-on Equity Offering in the amount of £6.5 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 69,111,111
Price\Range: £0.09
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 3,111,111
Price\Range: £0.09
Transaction Features: Regulation S; Subsequent Direct Listing Announcement • Jan 24
Verici Dx plc, Annual General Meeting, Feb 19, 2024 Verici Dx plc, Annual General Meeting, Feb 19, 2024, at 12:00 Coordinated Universal Time. Location: the offices of Shoosmiths London at No. 1 Bow Churchyard London United Kingdom Agenda: To approve the total number of new Ordinary Shares to be issued pursuant to the Fundraising and Admission. Announcement • Jan 08
Verici Dx plc Announces Medicare National Payment Rate for Tutiviatm and Claravatm Effective as of January 1, 2024 Verici Dx plc announced that the Centers for Medicare & Medicaid Services released the Clinical Laboratory Fee Schedule payment rate of $2,650 established through the "gapfill" process for both Tutiviatm (CPT 0320U), its post-transplant test focused upon acute cellular rejection, and Claravatm (CPT 0319U), its pre-transplant prognosis test for the risk of early acute rejection. This rate is effective as of January 1, 2024. Having a national payment rate established by CMS represents a step toward securing reimbursement for testing by Medicare, a national health insurance program in the US that covers 63.9 million patients. Gapfill pricing is a method used by CMS to establish a payment rate for clinical diagnostic laboratory tests when no comparable test is priced on the CLFS and involves setting the payment rate for the test at the median of rates established by local Medicare contractors. Announcement • Jul 22
Verici Dx plc Announces CLIA Certificate of Compliance Update US Clinical Laboratory Now Fully Accredited in 49 States Verici Dx plc announced that further to the RNS dated 2 March 2023, the Company has received compliance authorisation for the operation of its commercial clinical laboratory testing in respect of samples from an additional four US states, including the important addition of California, with the Company laboratory now fully accredited in a total of 49 states. Together with the CLIA certification previously obtained from the Centers for Medicare & Medicaid ("CMS"), clinicians at transplant medical centres in these additional states are now enabled to order Verici Dx's transplant tests, expanding the Company's commercial reach. California has consistently accounted for over 10% of the national US volume of kidney transplant procedures in each year since 1998 and has conducted the highest volume of transplants by any state each year over the same period. Verici Dx launched its first product, Tutivia™, for the detection of acute rejection in kidney post-transplant patients, in January 2023 and recently announced the successful validation of Clarava™, a first-in-class pre-transplant prognosis test for the risk of early acute rejection in deceased donor recipients, which it expects to launch later this year. The additional state accreditations provide further validation of Verici Dx's clinical laboratory for its tests to be used by transplant clinicians across the US. The Company continues to work towards full accreditation in the final state of New York, which has its own compliance requirements. The CLIA certification and additional state approvals further exemplify Verici's commitment to a quality-focused approach to providing advanced kidney transplant diagnostic services to clinicians and patients in need. Announcement • Jul 04
Verici Dx plc Announces Successful Validation Results from Its Prospective, Blinded, International Multi-Centre Clinical Validation Study for Clarava Verici Dx plc announced successful validation results from its prospective, blinded, international multi-centre clinical validation study for Clarava™?. Clarava™?, is the first pre-transplant prognostic test to enable measurement of a patient's immune response to assess the risk of early kidney graft rejection. The validation study represents a significant demonstration of Clarava™? as a predictive test capable of informing a clear, actionable response from clinicians for an estimated 65,000 eligible patients on an annual basis. Verici Dx is on track to commence the initial US commercial launch of Clarava™? before the end of 2023. The Company has received a preliminary Medicare gapfill median rate of $2,650 for Clarava™? from the Centers for Medicare & Medicaid Services. The Clarava™ study, which included a broad and diverse group of 122 patients preparing to receive a kidney transplant and a range of rejection outcomes across 13 centres, demonstrated a statistically significant result with a sensitivity of 78% and specificity of 64%, identifying patients that are at increased risk for a kidney rejection event in the critical first 60 to 90 days post-transplant, after receiving a kidney from a deceased donor ("DD"). Study data analysis of the clinical performance of Clarava™ demonstrated differentiation of high-risk and low-risk patient groups, determining that patients of high risk were approximately six times more likely to have a rejection than those of low risk. This represents a significant demonstration of Clarava™ as a predictive test capable of informing for a clear, actionable response from clinicians. Whilst DDs provide the majority of kidney transplants, the Company will be also exploring further samples drawn from Living Donor (LD) transplant recipients, in addition to assessing the anticipated combination of using our pre-transplant test, Clarava™ in conjunction with our post-transplant test, Tutivia™. Clarava™ is the only pre-transplant test of its kind that can risk stratify patients based on their likely immune response to a transplanted organ. This allows clinicians to identify patients most likely to require increased monitoring, including adjustments in the type, dose, and duration of immunosuppressive agents. Existing approaches to assess rejection risk are standardized and typically based on the recipient's race, age, previous transplant history and whether they have antibodies against common donor antigens. As reported, the Clarava™ personalized risk assessment is especially important for the expanding DD transplant population. Announcement • Jun 06
Verici Dx plc, Annual General Meeting, Jun 29, 2023 Verici Dx plc, Annual General Meeting, Jun 29, 2023, at 13:00 Coordinated Universal Time. Location: Avon House, 19 Stanwell Road, Penarth, Cardiff Wales United Kingdom Announcement • May 31
Verici Dx plc to Report Fiscal Year 2022 Results on Jun 05, 2023 Verici Dx plc announced that they will report fiscal year 2022 results on Jun 05, 2023 Board Change • Dec 31
High number of new and inexperienced directors There are 6 new directors who have joined the board in the last 3 years. The company's board is composed of: 6 new directors. 6 experienced directors. No highly experienced directors. Independent Non-Executive Chairman Julian Baines is the most experienced director on the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Announcement • Sep 07
Verici Dx plc Announces Positive Results for Clarava from Validation Study Verici Dx plc announced the successful outcomes from its blinded, international, multi-centre validation study for Clarava, the Company's pre-transplant blood-basedprognostic test for the risk of early acute kidney transplant rejection. Utilising a diverse validation population from 14 international transplant sites, the initial results of the validation study amongst the US kidney transplant patients followed up to date show that the Clarava diagnostic, which uses next-generation RNA sequencing, is an effective tool to identify patients likely to experience a future transplant rejection event prior to their surgery. Clarava represents a novel pre-transplant approach to characterising a patient's immune-profile using their RNA signature. This is expected to have wide-ranging implications regarding treatment plans for each patient ahead of transplant, post-operatively and in terms of monitoring patient response. The Directors believe that the available data on Clarava™ positions it as a viable and compelling product for a broader patient population and commercialisation, as it has no directly competing products. These initial results from the Clarava validation study therefore mark a further, important step toward clinical acceptance and commercialisation of the test. To generate broad clinical acceptance within the diverse international transplant community, Verici Dx is extending enrolment in its ongoing clinical validation study for an additional six-month period, using its existing network of 14 international transplant centres across Europe as well as the US. The expansion of the Clarava validation cohort is designed to enrich the utility data for the assay and support a statistically robust and clinically meaningful case for its adoption in due course. Announcement • Sep 05
Verici Dx plc to Report First Half, 2022 Results on Sep 07, 2022 Verici Dx plc announced that they will report first half, 2022 results on Sep 07, 2022 Announcement • Jun 09
Verici Dx plc Announces Appointment of Directors Verici Dx plc announced the senior appointments of Grant Harvey and Dr. Windy Tucci as Business Development Director and Medical Science Liaison Director, respectively, effective from June 9, 2022. Grant and Windy join the Verici Dx commercial team ahead of the planned commercial launch of Tuteva™, a post-transplant test focused upon acute cellular rejection, including sub-clinical rejection, which is expected to commence in the latter part of 2022. Grant Harvey, Business Development Director: Grant joined Verici Dx in June 2022 and brings more than 20 years of cross functional expertise in business development, sales leadership, marketing and training, as well as talent acquisition with a career portfolio of pharmaceuticals, medical services, and diagnostic products. Prior to partnering with the Verci Dx team, Grant served as a Senior GI Specialty Manager for Exact Sciences, a molecular diagnostics company specializing in the detection of early-stage cancers. Before joining Exact Sciences, Grant served as the Southeast Regional Director with USWorldmeds in the Parkinson's Disease space. Grant also held numerous senior leadership roles with Horizon Therapeutics,a biopharmaceutical company focused on researching, developing and commercializing medicines that address critical needs for people impacted by rare and rheumatic diseases. He also led national sales teams and key account managers in results-driven collaboration. As director of business development with Fresenius Medical, a German healthcare company which provides kidney dialysis services, he worked with nephrology practices and health systems to overcome marketplace challenges and capitalize on opportunities to improve outcomes and services for dialysis patients. Grant received his MBA from Elon University and his BS in Marketing from the University of North Carolina Wilmington. Dr. Windy Tucci,Medical Science Liaison Director: Dr. Windy M. Tucci joined Verici Dx earlier in 2022 with over 15 years of 'hands on' clinical patient care and Pharmaceutical Industry experience in therapeutic areas focusing on Transplant, Gastroenterology, Oncology, Neurology, Cardiology and Nephrology. She achieved her Doctorate in Pharmacy from the University of Florida, having previously graduated from Roger Williams University. Prior to Joining Verici Dx, she was the Clinical Lead for the south with Otsuka America Pharmaceutical, and led the Medical Science Liaison team with Exact Sciences where she worked directly with Health Systems, Large Specialty Practices, Healthcare Providers and professional organizations. In these roles, Windy was instrumental in developing new approaches to expand business opportunities, implement sales team expansion and new collaborations, and support pipeline clinical research initiatives. Announcement • May 26
Verici Dx plc, Annual General Meeting, Jun 27, 2022 Verici Dx plc, Annual General Meeting, Jun 27, 2022, at 14:00 Coordinated Universal Time. Location: Avon House, 19 Stanwell Road Penarth, Cardiff, CF64 2EZ Penarth United Kingdom Announcement • Apr 01
Verici Dx plc Provides Clinical Validation Study Update Verici Dx plc announced that whilst it has met the study size criteria, a decision has been taken to expand its clinical validation study for its lead products, ClaravaTM and TutevaTM, by approximately four to six weeks to allow the inclusion of more verified data from European sites, and therein increase the robustness of the study. The Board does not expect this to have any impact on the Company's recently outlined commercialization pathway and the Company remains on track to present results to the clinical community at ATC (American Transplant Congress) in early June, as planned. Verici Dx believes it will be able to meet its launch plans within this year, as expected. All the data from the validation study currently remains "blinded" and therefore the Company has not yet had access to the performance analysis of the study. The reason for this decision is due to a delay in compliance visits from the Company's European study sites. The inclusion of their data is significant as it contributes to ensuring an evenly distributed study population across all participating sites. This is an important aspect to ensure the robustness of the study for commercial launch. Unlike the U.S. sites, where compliance monitoring can be undertaken remotely, the sites in Italy, France, and Spain require onsite in-person monitoring, which has recently been hampered by restrictions due to COVID-19, hence the delay in inclusion of their data. Announcement • Feb 15
Verici Dx plc Announces Successful Completion of Analytical Validation for Clarava™ and Tuteva™ Verici Dx plc announced that its two lead in vitro diagnostic assays, Clarava™ and Tuteva™, have successfully completed analytical validation under the CLIA1 requirements, meeting comprehensive criteria for robust assay performance. Publication of the study will be made later in the year providing key data to support clinical use. Analytical validation is an essential element of defining the performance characteristics and platform capabilities of in vitro diagnostic assays, including reproducibility, accuracy, limits of detection, and risk of interferences for any clinician wanting comprehensive data about the reliability of testing. Data collected during analytical validation is essential for the subsequent clinical interpretation of assay results. The process to attain analytical validation is established by regulatory requirements under CLIA1, and its successful completion represents an important milestone towards commercialisation for both Clarava™ and Tuteva™ prior to the results of the clinical validation study expected at the end of First Quarter 2022. The analytical validation data also represents a significant milestone in the pathway to reimbursement. Under the Molecular Diagnostic Services Programme ("MolDx")2, which was developed to identify and provide coverage and reimbursement for molecular diagnostic tests under Medicare, the successful completion and submission of analytical validation studies, in addition to the clinical validation studies, are required for consideration of coverage. Clarava™ and Tuteva™, are novel, complex RNA expression next-generation sequencing assays coupled with proprietary prediction algorithms, that aim to understand a patient's pre and post kidney transplant immunologic response. The nature of assay processing for these tests requires specialised expertise that demonstrates precise results and for which all essential performance characteristics are verified. Announcement • Jan 06
Verici Dx plc Announces Clarava™ and Tuteva™ Complete Testing Requirements Verici Dx plc announces that its two leading products have completed the testing requirements of the multi-centre validation study, in line with the Company's expectations to have done so by the end of 2021. Reaching the clinical endpoints of the study means that, for both products, sufficient numbers of participants have completed the required follow-up to outcomes assessment, including biopsy findings, which are required for the full data analysis and clinical study report to be conducted in First Quarter 2022, as per the Company's targets. The Company's two leading products aim to understand how a patient will and is responding to kidney transplantation: Clarava™ is a pre-transplant prognosis test for the risk of early acute rejection; and Tuteva™ is a post-transplant test focused upon acute cellular rejection, including sub-clinical rejection as correlates to histopathology findings. The current fourteen clinical trial sites participating in the validation study for Clarava™ and Tuteva™ will continue the enrolment of patients for an extended period for the validation study of Protega and is expected to reach target by the end of Third Quarter next year. The potential to inform earlier clinical interventions with treatments such as anti-fibrotic therapies ahead of irreversible organ damage is another key step to improving transplant outcomes. Announcement • Jan 05
American Medical Association grants Verici Dx two CPT® Codes Verici Dx plc announced it has been granted CPT® Proprietary Laboratory Analyses ("PLA") codes1,2 for both its Clarava and Tuteva tests by the American Medical Association ("AMA"). The new codes have been approved and published by the AMA Editorial Panel and are scheduled to become effective on April 1, 2022. Announcement • Mar 17
Verici Dx plc to Report Fiscal Year 2020 Results on Apr 14, 2021 Verici Dx plc announced that they will report fiscal year 2020 results on Apr 14, 2021 Is New 90 Day High Low • Feb 09
New 90-day high: €1.04 The company is up 98% from its price of €0.52 on 10 November 2020. The German market is up 12% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 12% over the same period. Announcement • Feb 08
Verici Dx plc Announces Appointment of David Schultenover as Vice President of Quality and Regulatory Verici Dx plc announced the appointment of David Schultenover as Vice President of Quality and Regulatory with immediate effect to project manage this key objective for 2021. David Schultenover, who is an experienced pharmaceutical and medical device quality control & quality assurance management professional with proven success as a consultant and staff member in the scientific, medical, and manufacturing industries, will be responsible for the delivery of Clinical Laboratory Improvement Amendments (CLIA) laboratory approvals.
David joins Verici Dx from Thermo Fisher Scientific, where, as Senior Director of Regulatory, Quality and Compliance, he was responsible for 154 people covering regulatory affairs, Quality Assurance and Quality Control. Prior to that he was Quality Assurance Director at MiraVista Diagnostics. Announcement • Jan 12
Verici Dx plc Expands the Scope of Its License Agreement with the Icahn School of Medicine At Mount Sinai Verici Dx plc announces that it has expanded the scope of its license agreement with the Icahn School of Medicine at Mount Sinai ("Mount Sinai") to include an additional patent filing related to the analysis of gene expression in a blood-based test (liquid biopsy) to predict risk of fibrosis (chronic kidney graft damage) and rejection of the graft. Interstitial fibrosis and tubular atrophy (IF/TA) is a significant complication in 50-65% of transplants at 12-24 months and a major cause of graft rejection in the first year after transplantation. The development of a product that can predict risk of fibrosis and rejection using the Company's core technological approach would extend Verici Dx's portfolio across the full course of a patient's transplant journey and complement the Company's two in vitro diagnostic assays, Clarava and Tuteva. Clarava is a pre-transplant prognosis test for the risk of early acute rejection, and Tuteva is a post-transplant diagnostic focused upon acute cellular rejection. A further product using this technological approach and focused on risk of fibrosis would support the diagnosis of risk of longer-term graft failure as well. The development of a novel blood-based immune-phenotyping prognostic test for risk of fibrosis fits well with Verici Dx's current laboratory capabilities, instrumentation and expertise. Liquid biopsy also allows for easier deployment in clinical care given the limited population of transplant centres that undertake tissue allograft surveillance biopsies and the lower risk and costs associated with blood-based biopsies. The Company's multi-centre observational clinical study to validate the clinical performance of Clarava and Tuteva will also include patients being assessed for fibrosis for an extended study period beyond the initial end points for the first two products in order to collect data in support of validation for this newly licensed test to predict risk of fibrosis. Announcement • Dec 25
Verici Dx plc Appoints Angela Rose as Senior Director of Clinical Trial Operations Verici Dx plc announced that it has appointed Angela Rose as Senior Director, Clinical Trial Operations with immediate effect. Angela, a senior clinical trial project management professional with over 15 years of experience in managing medical device, diagnostics, biologic and drug global clinical trial operations for regulatory approval, will be responsible for overseeing Verici Dx's planned multi-centre observational clinical validation studies for its two in vitro diagnostic assays, Clarava and Tuteva. Angela joins Verici Dx from Humacyte Inc. Angela's extensive experience in clinical project management includes prior roles at BioCryst Pharmaceuticals Inc., Quintiles, Gilead Sciences Inc., and bioMérieux Inc. 
