GENinCode Plc announces California state licensing approval and CLIA certification of its Irvine laboratory in California, enabling the provision of its products for the risk assessment of CVD to patients across 49 states in the United States. The approval of the California state license by the California Department of Public Health and CLIA certification from the Centers for Medicare and Medicaid Services (CMS) marks a major milestone in the commercialisation of the Company's 'first in class' polygenic CVD products CARDIO inCode®and LIPID inCode®, which can now to be sold across the US and serviced from the Company's California CLIA lab. CARDIO inCode®measures an individuals inherited genetic risk of coronary heart disease with the complementary FDA 510K submission for a CARDIO inCode®kit (for use by other CLIA labs) to be filed shortly.

LIPID inCode®measures an individuals inherited genetic inability to metabolise LDL-C cholesterol (LDL-C is often referred to as 'bad cholesterol') giving rise to accelerated onset of heart disease. CARDIO inCode®and LIPID inCode®are now being prepared for entry into Early Access Programs with US revenue growth forecast from 2023. CARDIO inCode®measures the coronary genetic risk of a patient suffering a heart attack or cardiovascular event.

This new genetic information allows physicians to gain insight to a patient's coronary genetic risk score allowing more effective and earlier treatment to prevent heart disease. Physicians can now advise patients on their genetic risk of a coronary event and establish necessary changes to their lifestyle (e.g. reducing smoking, drinking or improving eating habits) as well as prescribing therapeutic treatment (e.g. statins, PCSK9i or other cholesterol lowering drugs) to prevent heart disease.