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.
UgenTec and R-Biopharm's collaboration will cover the software's development, regulatory approval, and launch.
The belief among genomics experts that one day drugs would be given based on genomic abnormalities that cut across tumor types became reality this week.
The New York State Department of Health had previously provided conditional approval of the microRNA classifier for diagnosing indeterminate thyroid cancer cases.
A man has confessed to the rape and murder of developmental biologist Suzanne Eaton, according to the New York Times.
The Irish Times reports that US lawmakers and law enforcement agencies are concerned about ties between the US and Chinese genomics firms.
Parents of children with spinal muscular atrophy tell the Washington Post they are pushing to get insurance coverage of Novartis's Zolgensma.
In PNAS this week: gene mutations in individuals with syndromic craniosynostosis, putative colorectal cancer drivers, and more.