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regulatory approval

The firm recently won $4.5 million as well as approval for its Fertilome test from New York state, though some have questioned the test's clinical utility.

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.

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NPR says the explosion and fire earlier this week at a Russian lab that stores dangerous pathogens revives the question of whether such samples should be kept.

According to Wired, Nebula Genomics is providing a way for people to get their genomes sequenced anonymously.

A 26-year-old woman tells Cosmopolitan about learning her APOE status at a young age.

In Science journals this week: a functional genomic screen uncovers drug combination that increases KRAS inhibitor efficacy in aggressive lung cancer, and more.