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parallel review pilot

After a five-year pilot, only one company has successfully taken a test through parallel review, but there is growing industry interest.

The company hopes to simultaneously achieve premarket FDA approval and a national coverage determination from CMS for its NGS cancer panel.

This article has been updated to note that Exact Sciences has previously said it will submit the Cologuard test for parallel review by FDA and CMS. Originally published Oct. 7.

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

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

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

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