Today the FDA published a pilot program using minimal performance criteria for companion diagnostics. When reading it, I regard this could benefit patients and labs. FDA seems to be looking into no more one-drug-one test using minimal performance criteria. I certainly applaud this; it’s about care and well-being of patients.
Reading the guidance, 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 publication of FDA’s group CDx guidance.
I think this is a great advancement but could also bring certain risks. I would like to share questions that arise when I read this:
Will the tests following the minimal performance criteria not be a CLASS III device?
What is then the value add for industry developing the first CDx?
Is it worth investing and as such, could it hamper or stagnate innovation and bringing emerging products to patients?
Will this lead to implementing the VALID act?
I am positive many more questions will arise. Looking forward to hear your thoughts for which you can use the comment field below, and what the pilot program will tell and bring us.