The NGS-based assays will be implemented at Memorial Sloan Kettering Cancer Center alongside targeted DNA sequencing assays to identify gene fusions.
The test, EXaCT-1, may not only help doctors find treatments for patients who have run out of options but may also provide biomarkers of immunotherapy response.
The test may help identify patients most likely to respond to Roche's new metastatic urothelial cancer drug Tecentriq, the FDA said.
The companion test will let doctors identify the best treatment for CLL patients with 17p deletions, a subset that has historically lacked therapeutic options.
The test, which was previously approved for CLL prognosis, is now cleared for use in identifying patients who may benefit from AbbVie and Genentech's Venclexta.
The approval comes after the FDA twice asked the company to provide additional data around the test's ability to boost screening compliance.
By showing flexibility and requiring a CDx in the post-market setting, the agency hopes to encourage the development of a universal NGS test.
The test, when used as intended, allows doctors to gauge the magnitude of benefit melanoma patients might derive from the immunotherapeutic Opdivo.
The Associated Press reports that the US Food and Drug Administration approved 45 new drugs last year.
Two editors at The Verge discuss investment into 'disruptive' healthcare companies.
Researchers tie a variant in ADAMTS3 to breathing difficulties in dissimilar dog breeds, according to Discover's D-brief blog.
The Japan Times reports that researchers sequenced the genome of a woman who lived during the Jomon period.
Parents of children with rare genetic disease have to contend with shifts in the interpretation of genetic variants, the Wall Street Journal reports.
In Science this week: single-nucleus RNA sequencing of brain tissue from individuals with autism, and more.