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.
Science speaks with the University of Michigan's Jedidiah Carlson, who has tracked population genetic discussions at white nationalist sites.
Gene therapies could qualify for a faster US Food and Drug Administration approval process, according to Stat News.
NPR reports that the US House of Representatives has passed a bill to enable terminally ill patients access to experimental drugs.
In Genome Research this week: inversion variants mapped in human, non-human primate genomes; transcriptome profiling of maize, sorghum; and more.