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FDA

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.

Hahn Hearing

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.

Despite the step-up in FDA action against labs offering PGx tests, the success of these programs suggests that access to them isn't being stifled as some feared.

The assay, which received premarket approval last year, detects 14 high-risk HPV types and individually identifies and reports HPV genotypes 16, 18, and 45.

Pages

Master's and doctoral students in the UK call on funding groups to extend their grants for the duration of the disruption caused by the COVID-19 outbreak, the Guardian reports.

Squid can make edits to their RNA within the cytoplasm of their axons, Science News reports.

The Chan Zuckerberg Initiative is putting $25 million toward COVID-19 treatment research, according to the Verge.

In Science this week: researchers engineer version of Cas9 that is nearly PAM-less, and more.