The FDA approved FoundationOne CDx and the Centers for Medicare and Medicaid Services concurrently issued a proposed national coverage decision for the test.
The test is designed to detect 14 of the most prevalent mutations in the gene responsible for the disease.
The wide-ranging discussion with witnesses from Stanford, Johns Hopkins, and Editas Medicine touched on recent advances in research and questions of safety.
The agency said that its action on MSK IMPACT "advances a policy framework that paves the way for the efficient review and availability of other NGS-based cancer profiling tools."
The NextSeq 550Dx is Illumina's second FDA-regulated CE-IVD platform for next-generation sequencing.
The test is performed on the company's AmpiProbe platform, and the approval expands Enzo's offering of infectious disease tests in New York.
The kits cover the primary genetic targets currently used for assessing the compatibility of hematopoietic cell donors with recipients.
BioCompute Objects provide a structured language and format for sharing computational protocols and procedures for next-generation sequencing data with regulatory agencies.
The test is intended for use by blood collection facilities and is not approved for the individual diagnosis of Zika infection.
The New York State Clinical Laboratory Evaluation Program has approved the company's FoundationACT blood-based circulating tumor DNA assay.
University of Idaho researchers model the scientific discovery process to examine the link between reproducibility and scientific truth.
A bill passed by a US House of Representatives appropriations subcommittee would give scientific agencies including the National Science Foundation boosts in funding.
Relocating USDA agencies outside of Washington, DC, may make them less effective, critics of the move tell NPR.
In PLOS this week: genes that help Borrelia burgdorferi survive in ticks, CiliaCarta collection of about 1,000 suspected cilia genes, and more.