Following discussions with the FDA, GENinCode has agreed to transition the FDA approval pathway for CARDIO inCode-Score (CIC-Score) to a De Novo submission from the previous 510(k) application. This transition will create a new regulatory class for polygenic risk score medical device tests and, assuming approval, could see CIC-Score established as the ‘predicate’ device against which future polygenic risk score tests are assessed, potentially creating a barrier to future competition given the cl ....
