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Genetics & Genomics Regulatory News & FDA Approvals

The latest regulatory news and FDA approvals.

The test runs on multiple GeneXpert systems and tests nasopharyngeal and nasal swabs or nasal wash/aspirate specimens.

Both RT-PCR tests are for the simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B from throat swab samples.

The nanopore sequencing-based test is designed to both diagnose SARS-CoV-2 infection, as well as monitor mutations that may affect efforts to combat the virus.

Both of the RT-PCR-based tests use healthcare provider-collected samples and may be used by any lab CLIA-certified to perform high-complexity tests.

The second EUA for a test that targets the ORF1a and N genes is for an automated version of a manual test that had been granted EUA in August.

Novavax has begun a phase III trial of its SARS-CoV-2 vaccine, according to the New York Times.

Vox reports that the Trump Administration may limit student visas for individuals from some countries to two years.

The governor of New York says the state will conduct its own review of any SARS-CoV-2 vaccine, NPR reports.

This week in Science: Neanderthal Y chromosomes replaced by Homo sapiens Y chromosomes, and more.

Oct
09
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As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.