FDA had begun exploring ways around the one-drug-one-test limitations of companion diagnostics by looking further into the ‘minimal performance criteria’ of these tests. It is FDA oncology chief Richard Pazdur, M.D.’s thinking that considering the minimal performance criteria of these tests would allow clinicians to use any test that meets the standard rather than the one-drug-one-test thinking.
To implement this proposed thinking, FDA is developing a pilot program. The pilot program will have the minimal performance criteria of a test embedded into a cancer drug’s clinical trial, which will then allow developers to select patients based on those criteria. These selection standards will then be made publicly available for clinicians to follow in clinical practice. This will allow physicians to select the best testing and treatment option for their patient’s needs.
Goldbug will continue to provide updates on the latest developments to this program and other CDx regulations as they become available.