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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.

The US has sent its formal notice of withdrawal from the World Health Organization, according to the Wall Street Journal.

Science reports that a draft spending bill would increase the US National Institutes of Health budget by 13 percent.

The Harvard Crimson reports that Harvard and MIT are suing the Department of Homeland Security and ICE over the new international student visa policy.

In Nucleic Acids Research this week: algorithm to determine molecular sequence types and other microbial features, computational method to uncover R-loop structures, and more.