The test MRSA and MSSA directly from blood culture samples in about one hour, compared to between 48 and 72 hours with other methods, the company said.
The Washington Post reports that a US Senate committee voted this week to approve the nomination of Stephen Hahn to lead the Food and Drug Administration.
The company is using the test to direct patient enrollment and treatment stratification in a trial of pembrolizumab (Keytruda) combination treatments.
The FDA approved FoundationOne CDx as a companion diagnostic for alpelisib in combination with fulvestrant to treat certain PIK3CA-mutated breast cancers.
The five-year FDA contract will add support for multi-omics data and various cloud-based analytical and statistical apps on the PrecisionFDA NGS platform.
The financing will go toward building out its sales teams in the US and Europe in order to market its multiplexed MDx tests for infectious diseases.
The company also said that it expects a clearance decision from US regulators in the near term on a lower respiratory tract infection test that runs on its Unyvero system.
The US Food and Drug Administration has approved an RNA interference drug to treat acute hepatic porphyria.
Stephen Hahn, the nominee to lead the US Food and Drug Administration, underwent a Senate confirmation hearing yesterday, the Washington Post reports.
Recent studies question the clinical utility of tumor mutational burden as a biomarker for immuno-oncology response, and the FDA clearance includes no therapeutic indications.
Forensic genetic firm Verogen has bought the genetic genealogy site GEDmatch.
Researchers have 3D-printed plastic bunnies that encase the information needed to make more such bunnies in DNA, according to Discover magazine.
Dan Rather, the former CBS Evening News anchor and executive producer of a new documentary, writes at the Guardian that everyone needs to know about CRISPR.
In PNAS this week: analysis of FOXA1 upregulation in ER-positive breast cancer, gene editing to correct recessive dystrophic epidermolysis bullosa, and more.