**Summary**
GENinCode Plc, an Oxford-based predictive genetics company, announced on December 3, 2025, that its CARDIO inCode-Score® <mark style="background-color:yellow">test</mark> has received approval from the New York State Department of Health’s Clinical Laboratory Evaluation Program. This approval enables full state coverage under the US Centers for Medicare and Medicaid Services (CMS), with reimbursement set at approximately $500 per test. The test, a polygenic risk score (PRS), predicts and aids in the prevention of coronary heart disease (CHD) by assessing an individual’s genetic risk through DNA extracted from saliva or blood samples.
The approval allows GENinCode to collect patient samples from New York State healthcare providers for testing at its Irvine, California lab. The company continues to engage with the FDA for De Novo assessment, aiming to submit additional data in Q1 2026 to enable broader commercialization of the test in the US.
CARDIO inCode-Score® has demonstrated clinical efficacy across multi-ancestry populations and is already adopted in the EU, UK, and US. It integrates into clinical pathways to personalize treatment and prevention strategies, reducing severe cardiovascular events and associated economic costs. CHD, the leading cause of death globally, affects over 250 million people annually, underscoring the significance of this preventive tool.
GENinCode’s CEO, Matthew Walls, expressed satisfaction with the approval, highlighting its importance for both New York State commercialization and ongoing FDA discussions. The test represents a significant advancement in public health, addressing the global burden of cardiovascular disease.