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GenInCode Files FDA 510(k) Submission For Polygenic Cardiovascular Disease Risk Test

NEW YORK – GenInCode announced Wednesday that it filed a 510(k) submission for its CARDIO inCode-Score (CIC-Score) in vitro polygenic risk score (PRS) test for cardiovascular disease with the US Food and Drug Administration.

The filing is part of the UK-based company's effort to expand the US commercial distribution of CIC-Score.

GenInCode currently offers the CIC-Score through the company's CLIA-certified and College of American Pathologists-accredited lab in Irvine, California, via an early access program.

The firm partnered with Milwaukee-based Eversana in 2021 to commercialize GenInCode's products within the US and last year filed its pre-submission for CIC-Score with the FDA.

The CIC-Score recently received a CPT PLA code (0401U) and the firm expects a payment rate for the test to be set by the US Centers for Medicare and Medicaid Services in October.

"Approval of the 510(k) kit/medical device filing will complement our US laboratory testing enabling GenInCode to accelerate commercial growth of CIC-Score in the US market," Matthew Walls, CEO of GenInCode, said in a statement. "Our early access program is seeing strong demand for use of our CIC-Score CLIA lab test to identify patients at high genetic risk, personalize treatment, and prevent [CVD]."