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.
Two researchers are calling for education for scientists on defending facts.
Researchers were among those who marched in London this weekend to call for another vote on Brexit.
Duke has agreed to pay $112.5 million to settle a lawsuit regarding its handling of data falsified by biologist Erin Potts-Kant.
In PLOS this week: genetic factors influencing inorganic arsenic metabolism and toxicity, a germline variant in the cell adhesion molecule-coding gene DSCAM, and more.