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Amid broader shift on LDT policy, FDA unveils pilot program for cancer drug-linked tests and diagnostics

A new FDA pilot program, deemed the Oncology Dx Pilot Program, and accompanying guidance document is focused on the development of minimum performance characteristics for the use of laboratory developed tests (LDTs) intended for use with specific oncology drugs based on information from the oncology drug sponsor. While the pilot has been in development for a while, the move comes as the FDA is looking towards a broader shift in its approach to LDTs.

Background: Diagnostics used to inform drug product use

Drug products, diagnostics and companion diagnostics (CDx): CDx are in vitro diagnostics (IVDs) “that provide information that is essential for the safe and effective use of a corresponding therapeutic product,” per FDA’s 2014 guidance document defining the term.

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