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News and reporting on ovarian cancer.
The company said investors have agreed to purchase $5.6 million of common stock as well as warrants that, if exercised, could raise an additional $5.1 million.
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.
The study showed an overall benefit regardless of BRCA mutation or HRD status, but some analysts believe the FDA still might require a CDx for niraparib.
Although Tesaro used Myriad's BRCA and HRD tests to stratify patients, in the NOVA trial all recurrent ovarian cancer patients benefitted from niraparib.
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.