FDA’s Draft Companion Diagnostics Guidance Document

For the In Vitro Companion Diagnostic Devices the main message is to develop the diagnostic and drug contemporaneously to ensure drug approval is not delayed. In summary, the FDA will require a submission (likely a PMA) for the diagnostic product that is specifically associated with a new drug (a companion diagnostic). If the companion diagnostic is an LDT then both CLIA and FDA requirements (i.e., submission and QSR compliance) will be required. For Laboratory Developed Tests (LDTs) that are available for the same marker, FDA staff has stated they will not currently be requiring PMAs.

The Commercially Distributed in Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions document reinforces current FDA regulation around distribution of products labeled Research Use Only (RUO) or Investigational Use Only (IUO). It states that manufacturers of RUO materials should stop selling to a specific customer if they become aware these materials are being used in clinical diagnostics (i.e., LDTs offered in a CLIA lab). The document explains there may be ways to move away from RUO labeling for reagent. There is also technical support available as a way to verify if manufacturers are knowingly supplying materials into a clinical diagnostic setting. Depending on how these regulations are enforced, they could have significant impact on LDTs and the diagnostics industry more broadly.