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.
Senator Lamar Alexander (R-Tenn.), who chairs the Senate health committee, will be retiring at the end of his term, Stat News reports.
UCSF researchers find that having two X chromosomes may contribute to women's longer lifespans, according to Discover's D-brief blog.
The Wall Street Journal reports on the US Centers for Disease Control and Prevention's use of genetic approaches to study foodborne illnesses.
In PNAS this week: immune cell profiling of wild baboons by social status, metabolomics profiling of esophageal tumors, and more.