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.