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.
In PLOS this week: nasal microbial communities in asthma patients; sequencing-based way to detect, track schistosomiasis; and more.
The New York Times speaks with Vanderbilt's John Anthony Capra about Neanderthal genes in modern humans.
A draft guidance from the FDA suggests the agency wants to more tightly control gene-edited animals, according to Technology Review.
Researchers were among this weekend's protesters bemoaning the new US administration, Vox reports.