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The test, which also is FDA-approved, can be used to identify best responders to three non-small cell lung cancer treatment regimens.
Pricing for FoundationOne CDx, which received FDA approval and a proposed CMS national coverage determination yesterday, will be determined under PAMA.
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.
Nearly 30,000 COVID-19 tests the UK sent to the US came back as void, according to the Telegraph.
New Scientist reports that both RNA and DNA may have been involved in the emergence of life on Earth.
Black principal investigators receive less favorable application scores when seeking US National Institutes of Health grants, the Chronicle of Higher Education reports.
In Nature this week: new Sperm-seq method enables crossover analysis, tumor-informed detection approach for minimal residual disease, and more.