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, personalise treatment and prevent [CVD].”