FDA clearance of the first NGS companion diagnostic paves the way for other comprehensive genomic profiling tests, but Foundation will have to educate docs on the benefits of its test.
The test is approved to identify patients who harbor BRCA mutations and are therefore more likely to respond to Clovis Oncology's ovarian cancer drug Rubraca.
Myriad filed the first PMA module with the FDA, though based on the agency's feedback it's unclear whether it will view myChoice HRD as a companion or complementary test.
According to Myriad, the NOVA study shows that myChoice HRD can double the number of ovarian cancer patients who will respond to niraparib compared to other tests.
Lynparza is just the start of an expansive portfolio of treatments targeting DNA damage response that AstraZeneca said it will advance with companion tests.
