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Genetics & Genomics Regulatory News & FDA Approvals

The latest regulatory news and FDA approvals.

The FDA last week also reissued an EUA for a PCR-based SARS-CoV-2 test from Quest Diagnostics to permit its use with pooled samples.

The RT-PCR-based test was first authorized earlier this year for the detection of SARS-CoV-2 nucleic acid in specimens collected by a healthcare provider.

The FDA also reissued Emergency Use Authorizations for SARS-CoV-2 tests from Roche and Express Gene to reflect their permitted use with additional sample types.

Cepheid said that the 4-in-1 test runs on any of almost 30,000 GeneXpert Systems, which provide results in approximately 36 minutes.

The kit is designed for use with samples stored in the company's CE-marked DNA/RNA Shield sample collection and preservation devices.

Bloomberg reports AstraZeneca may conduct another study of its candidate SARS-CoV-2 vaccine after dosing error.

Moderna is applying for an Emergency Use Authorization for its coronavirus vaccine, according to the New York Times.

The National Health Service is to conduct a trial of Grail's blood-based screening test for cancer.

In PLOS this week: somatic mutation patterns of glioblastomas among Lebanese patients, phenome-wide study using UK Biobank data, and more.