GenInCode, a UK-based company specializing in genetic testing, has taken a significant step toward expanding its presence in the United States by filing a 510(k) submission for its CARDIO inCode-Score (CIC-Score) polygenic risk score (PRS) test for cardiovascular disease with the US Food and Drug Administration (FDA).
The CIC-Score is a genetic test designed to assess an individual’s risk of developing cardiovascular disease (CVD) based on their genetic makeup. This filing represents GenInCode’s effort to enhance its commercial distribution of the CIC-Score within the United States, a key market for genetic testing and personalized medicine.
As of now, GenInCode provides access to the CIC-Score through its Clinical Laboratory Improvement Amendments (CLIA)-certified and College of American Pathologists-accredited laboratory located in Irvine, California. This access is made available through an early access program.
To facilitate its expansion in the US market, GenInCode entered into a partnership with Eversana, based in Milwaukee, in 2021. This collaboration aimed to commercialize GenInCode’s products within the United States, including the CIC-Score. Last year, the company took the initial step by filing a pre-submission for the CIC-Score with the FDA, indicating its intent to seek regulatory approval for the test.
One notable development in this process is the assignment of a Current Procedural Terminology (CPT) PLA code (0401U) to the CIC-Score. This code is essential for billing and reimbursement purposes and signifies that the test is recognized and can be reimbursed through insurance or government healthcare programs.
GenInCode now anticipates that the payment rate for the CIC-Score will be determined by the US Centers for Medicare and Medicaid Services (CMS) in October. This milestone is significant for making the test accessible and affordable to a broader population, as CMS plays a crucial role in establishing reimbursement rates for healthcare services and tests.