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.
Researchers believe that blocking c-Met and PARP1 may help patients with TNBC, and possibly other cancers, overcome resistance to PARP inhibitors.
Along with breast, ovarian, and pancreatic cancers, the "signature 3" mutation pattern was detected in around 10 percent of sequenced gastric tumors.
Officials from Genomic Health and Myriad Genetics updated investors and other attendees at the conference.
In Science this week: metagenomic-based technique for determining protein structure, and more.
An academic laments the rise of narcissism in the sciences, the Guardian reports.
Outgoing FDA commissioner Robert Califf writes in an editorial that the agency can help boost innovation.
The Trump transition team has asked NIH Director Francis Collins to remain at his post, though it's unclear for how long that will be.