Myriad said it will submit a supplementary premarket approval application for its BRACAnalysis CDx, which the FDA originally approved in 2014.
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.
Clovis hopes Sysmex's BEAMing test will work better than FFPE tests to identify candidates for treatment with rociletinib, its investigational EGFR inhibitor.
Interim data showed 40 percent of patients with a DNA repair signature experienced tumor shrinkage when treated with the drug.
Originally published August 8.
NEW YORK (GenomeWeb) – Clovis Oncology this week reported that the company had incurred a net loss for the second quarter of $34.8 million, compared to $19.3 million in the second quarter of 2013.
Originally published June 23.
FDA Clears Sequenom's IMPACT Dx to Aid Thrombophilia Diagnosis
The US Food and Drug Administration this week cleared Sequenom's IMPACT Dx Factor V Leiden and Factor II genotyping test.
Originally published June 1.
The US Food and Drug Administration has approved Alnylam's RNAi-based therapy Onpattro, according to Stat News.
Harvard Medical School's Seth Cassel and Cigall Kadoch argue in a Baltimore Sun op-ed that the recent TAILORx trial shows the potential of genomic-based medicine.
Researchers in the UK are working on using gene drives to control malaria-carrying mosquitoes, the Telegraph reports.
In PLOS this week: genetic architecture mediating gene expression, metabolomic patterns in multiple myeloma, and more.