https://www.fda.gov/news-events/press-announcements/fda-launches-pilot-program-help-reduce-risks-associated-using-laboratory-developed-tests-identify#:~:text=%E2%80%9CThe%20pilot%20aims%20to%20help,use%20of%20a%20corresponding%20treatment.
A pilot program to benefit patients and labs. FDA is looking into no more one-drug-one test using minimal performance criteria. I certainly applaud this for the care and well being of patients.
It seems that any test that meets these criteria could be used as CDx, rather than having to use only one specific test. This is coming ca. 2 years after the group CDx, see https://www.fda.gov/regulatory-information/search-fda-guidance-documents/developing-and-labeling-in-vitro-companion-diagnostic-devices-specific-group-oncology-therapeutic.
I think this is a great advancement, but could also bring certain risks. Will the next generation tests with the minimal performance criteria not be a CLASS III device? What is the value add for industry developing the first CDx? Is it worth investing and as such, will it hamper innovation and bringing emerging products to patients? Will this lead to implementing the VALID act? Many more questions will arise, I am positive. Looking forward what the pilot program will tell us.
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Esther Abels
Biomedical Regulatory Health Science Expert
Boston MA
United States
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