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).
Strata will refer castration-resistant prostate cancer patients with BRCA and ATM mutations for potential enrollment in Clovis' Rubraca studies.
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.
The BRCA Tumor MASTR Plus Dx assay identifies somatic mutations in the BRCA1 and BRCA2 genes in FFPE tumor tissue from ovarian cancer patients.
The company will use Myriad's myChoice HRD companion diagnostic to identify lung cancer patients who would be likely to respond to the drug.
Using DNA to sketch crime victims might not be a great idea, the NYTimes says.
Science has its own problem with sexual harassment. What do we do with the research these abusers produce, Wired asks.
Senate Republicans led by Senator Rand Paul (R-KY) are trying to change how the government funds basic research, reports ScienceInsider.
In Science this week: combining genomics and ecology to better understand the effects of natural selection on evolution, and more.