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.
Originally published April 23.
Originally published April 2.
Originally published Dec. 5.
By Turna Ray
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.
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Intel is ending its sponsorship of the International Science and Engineering Fair, the New York Times reports.