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The test is now approved as a CDx for advanced ovarian cancer patients considering Lynparza as a first-line maintenance treatment.
The test is approved to gauge germline BRCA mutations in advanced breast cancer patients who may benefit from treatment with Pfizer's PARP inhibitor Talzenna.
The analyst said Myraid's GeneSight and NIPT products present near-term opportunities that "should help power earnings upside in the years to come."
NGeneBio is moving ahead with plans to have the test cleared for diagnostic use in Korea, while envisioning a 2019 submission to the US FDA.
The test is approved as a tool to identify which patients with a kind of ovarian cancer are likely to benefit most from Tesaro's Zejula (niraparib).
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.