Announcement • Jun 18
GENinCode Plc, Annual General Meeting, Jul 01, 2026 GENinCode Plc, Annual General Meeting, Jul 01, 2026. Location: the offices of cavendish capital markets, one bartholomew close, ec1a 7bl, london United Kingdom New Risk • Jun 09
New major risk - Revenue and earnings growth Earnings have declined by 14% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (250% average daily change). Earnings have declined by 14% per year over the past 5 years. Shareholders have been substantially diluted in the past year (162% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable next year (UK£3.6m net loss next year). Revenue is less than US$5m (UK£3.1m revenue, or US$4.1m). Market cap is less than US$100m (€8.73m market cap, or US$10.1m). Reported Earnings • Jun 09
Full year 2025 earnings released: UK£0.021 loss per share (vs UK£0.025 loss in FY 2024) Full year 2025 results: UK£0.021 loss per share. Revenue: UK£3.08m (up 14% from FY 2024). Net loss: UK£5.71m (loss widened 29% from FY 2024). Announcement • May 23
GENinCode Plc to Report Fiscal Year 2025 Results on May 22, 2026 GENinCode Plc announced that they will report fiscal year 2025 results at 8:00 AM, GMT Standard Time on May 22, 2026 Announcement • May 22
GENinCode Plc to Report Fiscal Year 2025 Results on Jun 08, 2026 GENinCode Plc announced that they will report fiscal year 2025 results at 8:00 AM, GMT Standard Time on Jun 08, 2026 Board Change • May 20
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. 7 experienced directors. No highly experienced directors. Independent Non-Executive Director Felix Frueh was the last director to join the board, commencing their role in 2022. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Announcement • Jan 27
GENinCode Plc has completed a Follow-on Equity Offering in the amount of £0.200141 million. GENinCode Plc has completed a Follow-on Equity Offering in the amount of £0.200141 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 20,014,095
Price\Range: £0.01 Announcement • Oct 28
GENinCode plc Announces the Publication of Major Clinical Study in JACC: Advances Evaluating the Company's Cardio InCode-Score®? Polygenic Risk Score for Coronary Heart Disease GENinCode Plc announced the publication of a major clinical study in JACC: Advances evaluating the Company's CARDIO inCode-Score®? Polygenic Risk Score ("PRS") for coronary heart disease ("CHD"). JACC: Advances, a medical journal which is part of the Journal of the American College of Cardiology (JACC), specifically focuses on the latest research in cardiovascular medicine including new treatments, technologies and scientific discoveries in Cardiology leading to better clinical practices in the medical field. The peer-reviewed study, titled "Joint Consideration of LDL-C and Polygenic Risk for Coronary Heart Disease Risk Assessment", was conducted by researchers at Kaiser Permanente's Department of Research and Department of Cardiology in San Francisco, California, USA. The Kaiser Permanente study followed over 47,000 individuals of diverse ancestry for 14 years, analysing the relationship between low-density lipoprotein cholesterol (LDL-C) and polygenic risk for coronary heart disease. Participants were assessed for the incidence of CHD events including myocardial infarction (heart attack). The CARDIO inCode-Score(®? PRS was used to quantify each participant's inherited risk of CHD based on genetic variation across the genome. The study examined whether the effect of LDL-cholesterol on CHD risk was modified by an individual's underlying genetic risk. The results demonstrated that genetic risk significantly influences the relationship between LDL-cholesterol and coronary heart disease, with the combination of elevated LDL-C and high PRS conferring substantially greater risk. Individuals with high polygenic risk experienced a 75% increase in CHD risk at LDL-C levels as low as 100 mg/dL (2.6 mmol/L) (Hazard Ratio: 1.75); The combination of a high PRS and LDL-C of 190 mg/dL (4.9 mmol/L) or higher was associated with a greater than 3.5-fold increase in CHD risk, comparable to the risk observed in patients with heterozygous familial hypercholesterolemia (FH), a well-established genetic condition conferring very high cardiovascular risk. These findings confirm that polygenic risk acts as a powerful modifier of LDL-cholesterol-related CHD risk, supporting its use in clinical decision-making and preventive care. Clinical and Preventive Implications This study underscores the critical role that integrating genetic data with clinical assessments can play in revolutionising cardiovascular risk stratification and prevention and guide earlier intervention in at-risk populations. Individuals with high genetic risk may benefit from more proactive lipid management and lifestyle or therapeutic intervention, even at LDL-C levels traditionally considered low or moderate. By integrating polygenic risk assessment into existing clinical pathways, healthcare providers can more accurately identify individuals at heightened lifetime risk of CHD and personalise prevention strategies. This can also reduce the incidence of severe cardiovascular events, such as heart attacks and strokes, and potentially mitigate the economic costs associated with long-term heart disease care. This approach can be seen as a significant step toward improving public health outcomes, particularly in addressing the global burden of cardiovascular disease. Dr. Richard Kovacs, Q.E. and Sally Russell Professor of Cardiology at the Indiana University School of Medicine and Chief Medical Officer of the American College of cardiology and Past President of the American College of Cardology said: " These results provide further compelling clinical evidence for the inclusion of polygenic risk scores (PRS) in conjunction with clinical risk for improved risk assessment of CHD. The polygenic risk score is especially important in relation to patients clinically classified at borderline/intermediate risk and younger patients with a family history of CHD. The recent scientific statements and acknowledgment of the value of PRS by the American College of Cardiology and American Heart Association is also welcome". Announcement • Sep 05
GENinCode Plc to Report First Half, 2025 Results on Sep 30, 2025 GENinCode Plc announced that they will report first half, 2025 results on Sep 30, 2025 Announcement • Jul 07
GENinCode Plc Announces an Update on Its Food and Drug Administration De Novo Submission GENinCode Plc announced an update on its Food and Drug Administration (FDA) De Novo submission. In response to a request by the Company for a Supervisory Review, the FDA recently provided a review of its April 2025 assessment. While the number of the outstanding deficiencies has been reduced, the review upheld the FDA's prior view that there remains certain outstanding elements, including further information in relation to clinical validation. With the feedback from the Supervisory Review, the Board remains of the view that there is a path forward to provide the further information to resolve these deficiencies to obtain De Novo classification. Discussions with the FDA have been productive with the outstanding deficiencies reducing. The Board does not believe that there are any elements that it cannot address, however there can be no certainty that the information provided will be sufficient. The Company has arranged further ongoing clarifictory discussions with the FDA and will provide a further update if this provides additional information. Announcement • Jun 13
GENinCode Plc, Annual General Meeting, Jun 30, 2025 GENinCode Plc, Annual General Meeting, Jun 30, 2025. Location: the offices of cavendish capital markets, one bartholomew close, ec1a 7bl, london United Kingdom Announcement • May 16
GENinCode Plc to Report Fiscal Year 2024 Results on Jun 04, 2025 GENinCode Plc announced that they will report fiscal year 2024 results at 8:00 AM, GMT Standard Time on Jun 04, 2025 Announcement • May 02
Genincode plc Announces an Update on Its Food and Drug Administration De Novo Submission GENinCode Plc announced an update on its Food and Drug Administration De Novo submission. The FDA has provided full feedback on the application and determined that there remains certain outstanding elements, including deficiencies in relation to clinical validation, that need to be addressed. The Company has initiated a Supervisory Review with the FDA to address these elements and is holding ongoing discussions and in-person meetings with the FDA to resolve these deficiencies. The Board does not believe that there are any elements that it cannot address, however there can be no certainty that the information provided will be sufficient. The Company will provide a further update at the Preliminary Results at the end of May 2025. Announcement • Jan 23
GENinCode plc Announces Inclusion of Cardio inCode inCode in the US 2025 Clinical Lab Fee Schedule GENinCode Plc announced the inclusion of CARDIO inCode (for the polygenic risk assessment of coronary heart disease) in the US 2025 Clinical Lab Fee Schedule (CLFS) to enable reimbursement from Medicare and Medicaid across the US. The company also announces the implementation of CARDIO inCode for the prevention of coronary heart disease (CHD) in the Spanish region of Barcelona. The CARDIO inCode-Score test is being clinically adopted across leading US healthcare institutions and has now been included in the Centers for Medicare and Medicaid Services (CMS) Clinical Lab Fee Schedule (CL FS) from 2025. The CARDIO inCode test (CPT code: 0401U) price varies on a state by state basis ranging from $450 - $570 with a median price of ~ $500/test. The company is also progressing its FDA ' de novo' submission for CARDIO inCode and expects to provide an update on progress over the coming months. Following earlier CARDIO inCode test pilots across Spain, the Barcelona ministry of health has agreed to implement CARDIO inCode to improve the risk assessment of cardiovascular disease in primary care through the Barcelona Health Institute - ICS ("Institut Catala de la Salut"). Barcelona is one of 17 Spanish regions providing state based health services to prevent CHD. Out of a total Spanish population of approximately 48 million, the Barcelona region has a population of 7.7m. CARDIO inCode will be provided to patients aged between 45 to 64 years targeting those at risk of CHD estimated at up to 476,000 patients in the Barcelona region. Test volumes are expected to escalate up to approximately 1,000 patient tests through this year with volumes expanding as increasing numbers of physicians, community practices and regions are educated and onboarded for testing. The Company is also progressing pilot preparations for CARDIO inCode in other Spanish regions. GENinCode specialises in polygenic risk assessment for the prevention of CHD. CHD is the most common form of heart disease and the leading cause of death worldwide and in the United Kingdon and United States. In the UK around 7.6m people live with heart and circulatory disease, which causes 25% of all deaths annually. CHD can be reduced by identifying and treating individuals at risk, and the NHS 10 Year Plan (2019) focused on addressing CVD prevention. New Risk • Oct 23
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: €8.32m (US$8.97m) 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£6.1m free cash flow). Earnings have declined by 37% per year over the past 5 years. Shareholders have been substantially diluted in the past year (85% increase in shares outstanding). Market cap is less than US$10m (€8.32m market cap, or US$8.97m). Minor Risks Share price has been volatile over the past 3 months (10.0% average weekly change). Revenue is less than US$5m (UK£2.6m revenue, or US$3.4m). Reported Earnings • Sep 27
First half 2024 earnings released: UK£0.014 loss per share (vs UK£0.037 loss in 1H 2023) First half 2024 results: UK£0.014 loss per share (improved from UK£0.037 loss in 1H 2023). Revenue: UK£1.39m (up 46% from 1H 2023). Net loss: UK£2.43m (loss narrowed 31% from 1H 2023). New Risk • Sep 16
New minor risk - Financial data availability The 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 Less than 1 year of cash runway based on free cash flow trend (-UK£7.5m free cash flow). Earnings have declined by 46% per year over the past 5 years. Shareholders have been substantially diluted in the past year (85% increase in shares outstanding). Minor Risks Latest financial reports are more than 6 months old (reported December 2023 fiscal period end). Currently unprofitable and not forecast to become profitable next year (UK£5.3m net loss next year). Share price has been volatile over the past 3 months (11% average weekly change). Revenue is less than US$5m (UK£2.2m revenue, or US$2.8m). Market cap is less than US$100m (€14.2m market cap, or US$15.7m). Announcement • Sep 09
GENinCode Plc to Report First Half, 2024 Results on Sep 25, 2024 GENinCode Plc announced that they will report first half, 2024 results on Sep 25, 2024 Announcement • Jun 09
GENinCode Plc, Annual General Meeting, Jun 27, 2024 GENinCode Plc, Annual General Meeting, Jun 27, 2024. Location: the offices of cavendish capital markets, one bartholomew close, ec1a 7bl, london United Kingdom New Risk • Jun 04
New major risk - Revenue and earnings growth Earnings have declined by 46% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. 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£7.5m free cash flow). Share price has been highly volatile over the past 3 months (24% average weekly change). Earnings have declined by 46% per year over the past 5 years. Shareholders have been substantially diluted in the past year (85% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable next year (UK£4.6m net loss next year). Revenue is less than US$5m (UK£2.2m revenue, or US$2.8m). Market cap is less than US$100m (€16.1m market cap, or US$17.5m). Reported Earnings • Jun 04
Full year 2023 earnings released: UK£0.07 loss per share (vs UK£0.058 loss in FY 2022) Full year 2023 results: UK£0.07 loss per share (further deteriorated from UK£0.058 loss in FY 2022). Revenue: UK£2.16m (up 51% from FY 2022). Net loss: UK£7.02m (loss widened 26% from FY 2022). Announcement • May 24
GENinCode Plc to Report Fiscal Year 2023 Results on Jun 03, 2024 GENinCode Plc announced that they will report fiscal year 2023 results on Jun 03, 2024 New Risk • Apr 07
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended June 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 (23% average weekly change). Shareholders have been substantially diluted in the past year (85% increase in shares outstanding). Minor Risks Latest financial reports are more than 6 months old (reported June 2023 fiscal period end). Currently unprofitable and not forecast to become profitable next year (UK£5.6m net loss next year). Revenue is less than US$5m (UK£1.7m revenue, or US$2.2m). Market cap is less than US$100m (€19.4m market cap, or US$21.0m). Announcement • Apr 04
GENinCode Plc Announces Publication by the American Journal of Preventive Cardiology of A Study on 'Polygenic Risk and Incident Heart Disease in a Large Multiethnic Cohort GENinCode Plc announced the publication by the American Journal of Preventive Cardiology of a study on 'Polygenic Risk and Incident Heart Disease in a large multiethnic cohort'. The Kaiser Permanente Division of Research study investigated more than 63,000 adult individuals with no history of Coronary Heart Disease (CHD) who are part of the Kaiser Permanente Northern California Genetic Epidemiology Resource in Adult Health and Aging (GERA) multi-ethnic cohort. The GERA cohort followed the membership over an average of 14 years, using CARDIO inCode-Score® to assess the polygenic risk of CHD and future incidence of risk of CHD. The study found that CARDIO inCode-Score®can identify individualsatthe highestrisk ofCHD. These individuals shouldthenbe prioritised for lifestyle adviceand where appropriate therapeutic interventionas they will benefit the most. Previous data with CARDIO inCode-Score®has shown that, for individuals with a high genetic risk, a favourable lifestyle is associated with a 52% lower rate of CHD compared with an unfavourable lifestyle. CHD 'event' includes:non-fatal AMI, angina or coronary atherosclerosis, coronary revascularisation procedures (coronary by-pass or percutaneous intervention) or CHD death. The study underlines the need for 'polygenic risk score' lifetime risk assessment in conjunction with traditional clinical risk assessment to optimise preventive care strategies to lower the future risk of CHD. Polygenic risk assessment can be undertaken in younger people, before conventional clinical risk factors (such as high blood pressure, diabetes etc.) have developed and can be combined with conventional risk scoring in older people. In this way clinicians can better identify those most likely to benefit from lifestyle and therapeutic intervention.GENinCode is commencing its commercialisation ofCARDIO inCode-Score®(or CIC-SCORE) with leading healthcare institutions in the United States to provide an improved estimation of an individual's risk of heart attack over their lifetime. CIC-Score is being delivered from the GENinCode CLIA and CAP approved laboratory in Irvine, California. The Company filed its CIC-Score 'De Novo' medical device submission with the FDA at the end of last year. The Company continues to progress its submission for FDA approval of the CIC-SCORE medical device to enable the scale up and processing by labs across the United States. New Risk • Feb 01
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of German stocks, typically moving 7.3% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Shareholders have been substantially diluted in the past year (85% increase in shares outstanding). Market cap is less than US$10m (€8.82m market cap, or US$9.53m). Minor Risks Currently unprofitable and not forecast to become profitable next year (UK£6.5m net loss next year). Share price has been volatile over the past 3 months (7.3% average weekly change). Revenue is less than US$5m (UK£1.7m revenue, or US$2.2m). Announcement • Dec 28
GENinCode Plc has completed a Follow-on Equity Offering in the amount of £4.057378 million. GENinCode Plc has completed a Follow-on Equity Offering in the amount of £4.057378 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 67,576,000
Price\Range: £0.05
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 12,424,000
Price\Range: £0.05
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 1,147,560
Price\Range: £0.05
Transaction Features: Rights Offering; Subsequent Direct Listing Announcement • Nov 29
GENinCode plc Agrees with the Food and Drug Administration to Create New Regulatory Class for Polygenic Risk scores and Transition Its Premarket Notification 510(K) Submission to A De Novo Pathway GENinCode Plc announced it has agreed with the Food and Drug Administration (FDA) to create a new regulatory class for polygenic risk scores and transition its premarket notification 510(k) submission to a De Novo submission. The new regulatory class clearance of CARDIO inCode will enable GENinCode to commercially advance US national distribution of the CARDIO inCode-Score polygenic test kit (medical device) for the risk assessment and prevention of Coronary Heart Disease ("CHD"). Following the CARDIO inCode- Score 510(k) medical device submission in August 2023, the FDA has reviewed the submission and recently noted CARDIO inCode-Score's 'first in class' position and the deep clinical evidence for polygenic risk assessment of CHD. Based on these factors and the novel position of CARDIO inCode-Score, the FDA has requested the Company to transition to a De Novo pathway for market approval. The crossover to a De Novo pathway enables the Company to work with the FDA to establish a new polygenic regulatory class for the CARDIO inCode- score medical device based on its favourable benefit-risk profile and associated special controls thereby setting a new regulatory standard for future polygenic tests in this class. Following the FDA request, the Company has now submitted its De Novo submission for market clearance and expects a timeline to clearance broadly in line with earlier the earlier 510(k) submission forecasts of late first quarter/early second quarter 2024. CARDIO inCode-Score or CIC-SCORE is an in-vitro diagnostic test used to assess an individual's polygenic risk of CHD based on DNA analysis. Published clinical evidence amassed over the past 15 years shows that the test when combined with traditional clinical risk assessment, provides a comprehensive risk assessment of CHD for use in primary preventive care. GENinCode processes and delivers the CIC-SCORE test results to physicians via its online 'SITAB' cloud based reporting system. The CIC-SCORE test addresses the well-recognised need to improve the CHD standard of care by providing a genetic (polygenic) risk assessment for CHD, thereby improving preventive care, patient management, and personalised treatment. GENinCode has commenced Early Access Programs for CARDIO inCode-Score with leading institutions in the United States to provide an improved estimation of an individual's risk of heart attack over their lifetime. The test is currently being delivered from the GENinCode CLIA and CAP approved laboratory in Irvine, California. New Risk • Oct 10
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: €9.16m (US$9.71m) 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£7.1m free cash flow). Earnings are forecast to decline by an average of 12% per year for the foreseeable future. Market cap is less than US$10m (€9.16m market cap, or US$9.71m). Minor Risks Currently unprofitable and not forecast to become profitable next year (UK£7.5m net loss next year). Share price has been volatile over the past 3 months (8.0% average weekly change). Revenue is less than US$5m (UK£1.7m revenue, or US$2.1m). Announcement • Sep 22
GENinCode Plc Provides Revenue Guidance for the Second Half of 2023 GENinCode Plc provided revenue guidance for the second half of 2023. Over the second half of 2023 the company will continue to strengthen revenues across its UK and EU business and transition its US Early Access Program to start commercially selling CARDIO inCode-Score (CIC-SCORE) and LIPID inCode. The company is focused on scale-up and revenue growth across its core EU, UK and US markets, gaining FDA regulatory approval and reimbursement coverage for CARDIO inCode-Score whilst taking advantage of US reimbursement coverage for its familial hypercholesterolemia test LIPID inCode. Over the remainder of this financial year, the company expects to complete the following key deliverables: Significant growth in year-on-year revenues. Successful delivery of US Early Access Programs and first US revenues. Announcement • Sep 14
GENinCode Plc to Report First Half, 2023 Results on Sep 20, 2023 GENinCode Plc announced that they will report first half, 2023 results on Sep 20, 2023 Announcement • Sep 01
Genincode plc Announces CARDIO inCode study on risk of incident Coronary Heart Disease GENinCode Plc announced the presentation by Kaiser Permanente, US on the ' Utility of the CARDIO inCode-Score®? CHD polygenic risk score for incident coronary heart disease interplay with lifestyle in a multi-ethnic cohort of more than 60,000 individuals'. The presentation was made at the Annual Meeting of the European Society of Cardiologists Congress over 25-28 August 2023 in Amsterdam. The study investigated over 60,000 adult individuals with no history of Coronary Heart Disease (CHD) from the Genetic Epidemiology Resource in Adult Health and Aging (GERA) multi-ethnic cohort of the Kaiser Permanente Medical Care plan of Northern California, USA. The GERA cohort followed the membership over an average of 14 years, using CARDIO inCode-Score to assess the polygenic risk of CHD, interplay with lifestyle and the incidence of CHD. Other recently announced news As previously announced, GENinCode is commencing Early Access Programs for CIC-SCORE (or CARDIO inCode- Score®?) with leading healthcare institutions in the United States to provide an improved estimation of an individual's risk of heart attack over their lifetime. CIC-Score is now being commercially delivered from the GENinCode CLIA and CAP approved laboratory in Irvine, California. As also announced, the Company has recently filed its CIC-Score pre-market notifification (510k) medical device filing with the FDA. The Company expects to receive FDA approval for the CIC-SCORE medical device over the next 6 months enabling scale up and processing by CLIA labs across the United States. In the UK around 7.6m people live with heart and circulatory disease, which causes 25% of all deaths annually. CVD can be reduced by identifying and treating individuals at risk, and the NHS 10 Year Plan (2019) sets out to address CVD prevention. Announcement • Aug 17
GENinCode plc Files its Premarket Notification (510k) with the Food and Drug Administration to Expand Its US Commercial Distribution of the Cardio InCode-Score Polygenic Test for the Risk Assessment and Prevention of Coronary Heart Disease GENinCode Plc announced it has filed its Premarket Notification (510k) with the Food and Drug Administration (FDA) to expand its US commercial distribution of the CARDIO inCode-Score ("CIC-SCORE") polygenic test for the risk assessment and prevention of Coronary Heart Disease ("CHD"). CIC-SCORE is a in-vitro diagnostic test used to assess an individual's polygenic risk of CHD based on DNA analysis. The test is based on published clinical evidence amassed over the past 15 years which combined with traditional clinical risk provides a comprehensive risk assessment of CHD for use in primary preventative care. GENinCode processes and delivers the CIC-SCORE test results to physicians via its online 'SITAB' cloud based reporting system. The CIC-SCORE test addresses the well-recognised need to improve the CHD standard of care by providing a step change in patient risk assessment for CHD thereby improving preventative care, patient management, and personalised treatment. GENinCode has commenced Early Access Programs for CIC-SCORE with leading institutions in the United States to provide an improved estimation of an individual's risk of heart attack over their lifetime. The test is currently being delivered from the GENinCode CLIA approved laboratory in Irvine, California. The Company expects to receive FDA approval of the premarket notification for the CIC-SCORE kit/medical device over the next 6 months enabling scale up and processing by CLIA labs across the United States. The Company also announces that it has received the College of American Pathologist ("CAP") laboratory accreditation for the CIC-SCore test delivered from the Company's US laboratory based in Irvine, California. This follows receipt of California State Licensing and CLIA approval earlier this year. The 510k filing follows the recently announced CPT PLA code (0401U) for CIC-SCORE which was approved and published by the AMA CPT Editorial Panel. A payment rate for the new code will be established for Medicare patients through the Clinical Lab Fee Schedule ("CLFS") Annual Public Meetings with a pricing decision on CIC-SCORE expected in October. This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014, as it forms part of domestic law by virtue of the European Union (Withdrawal) Act 2018. Identifying those at highest risk of CVDs and ensuring they receive appropriate treatment can prevent premature deaths. Access to noncommunicable disease medicines and basic health technologies in all primary health care facilities is essential to ensure that those in need receive treatment and counselling. The current standard of care for assessing cardiovascular risk is primarily based on traditional clinical risk factors such as age, sex, smoking, body mass, blood pressure and cholesterol levels from which individuals are categorised as being at low, moderate or high risk of a CVD event. This categorisation is imperfect as CVD events frequently occur in those thought to be at low or moderate risk. The size of the populations at low or moderate risk are much larger than those at high or very high risk so whilst the relative risk of a CVD event may be small, the absolute number of CVD events in low and moderate risk populations is much greater than the number of events in higher risk categories. Clinicians have for many years recognised the importance of prior CVD events within the families of their patients because genetic factors contribute to the development of atherosclerosis and a patient's family history has become a surrogate for their inherited genetic risk. In recent years, with the advances of genomics, it has proved possible to add genetic profiling to conventional CVD risk factors, the combination of the two (genetics and conventional clinical risk factors) enhancing the predictive capability of patient risk thereby resulting in a personalised and preventative approach to CVD. 
