The agency finalized recommendations for developing and validating NGS tests, and proposed a submission process for investigational IVDs in cancer Rx trials.
The test is approved as a companion diagnostic that can determine which advanced breast cancer patients have BRCA1/2 genetic mutations and will likely respond to Lynparza.
FDA's blessing for 23andMe's test that gauges select BRCA1/2 variants has the cancer community worried about whether consumers will understand its limitations.
The Artus T. vaginalis QS-RGQ kit is designed for the qualitative detection of Trichomonas vaginalis DNA purified from clinician-collected patient samples.
The Blood Profiling Atlas in Cancer Consortium released its first public data last month, revealing some of its work with the US Food and Drug Administration.
With the accreditation, the La Jolla, California-based molecular dermatology firm can provide its services in all 50 states and the District of Columbia.
The test reduces hands-on time by enabling labs to simultaneously assess Factor II and Factor V gene mutations from a single patient sample, Roche said.
Lawmakers have asked four direct-to-consumer genetic testing companies to explain their privacy policies and security measures, according to Stat News.
