In a Phase III trial, talazoparib-treated patients had a three-month median progression-free survival advantage over patients treated with chemotherapy chosen by their doctors.
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.
Mice in New York harbor both antibiotic-resistant bacteria and novel viruses, according to a new analysis of their fecal microbiomes.
Human Heredity and Health in Africa Initiative has issued guidelines for genomic research in the region, according to Nature News.
The Associated Press reports that an ethicist predicts that prenatal diagnosis and other advances will lead to more choices being available to prospective parents.
In Genome Biology this week: approach to analyze alternative polyadenylation, algorithm to predict transcriptomic structural variations, and more.