Companion diagnostics are being developed to try to identify patient groups (or subgroups) that will respond best to a given therapy. It is hoped that this will give better results in the clinic for responder populations and will spare non-responders from exposure to potential side effects of drugs that will not work for them.
The FDA recommends that there be early engagment between the agency and developers of such tests. It says it now plans to review the diagnostics and therapies in tandem -- where both exist. The FDA says it will still approve therapies with no diagnostic for very serious illnesses with no other available treatments. In such an instance, the companion test might receive later approval.
"These proposed guidelines support the development of innovative new targeted medicines and their corresponding diagnostic tests and are intended to provide manufacturers with greater predictability," said CDRH director Jeffrey Shuren. See Fierce Biotech.
Posted by Bruce Lehr July 14th 2011.