Tuesday, April 14, 2020

FDA Releases Guidance for CDx for Groups of Drugs

In December 2018, FDA authors had an article in one of the Nature journals and released a draft guidance on companion diagnostics for groups of oncology drugs.  This policy advance promised to relieve CDx developers, and FDA staff, of the pretense that a given CDx can be approved for only of of a group of virtually identically-acting drugs (on the same genes, same location, same mutation.)  Or the somewhat nutty concern that a hospital, laboratory, and oncologist must use PCR IVD "X" for EGFR Drug A, and PCR IVD "Y" for EGFR Drug B to ensure that drug use is "on label" for payers.

On April 13, 2020, FDA released the final version of the guidance.

  • FDA home page here.
  • FDA Federal Register page here.
  • FDA guidance, here.  12pp.
  • Press at Genomeweb, here.