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North Dakota-based MedScan Laboratory will collect patient samples and extract RNA for Fulgent's new NGS-based clinical assay for SARS-CoV-2.
The sponsors of the VALID Act say it's time to modernize outdated diagnostic regulations slowing down test access during a public health crisis.
Regulators told the lab industry that they can continue to offer PGx lab tests without FDA approval if they make evidence-based claims.
Genentech will use Adaptive's ClonoSeq assay for MRD testing in a CLL study. Adaptive will receive upfront and sample testing payments of undisclosed amounts.
The group wants the agency to allow labs to discuss gene-drug relationships with "adequate evidence" in test reports and hold a public meeting.
Lexent's NGS assay for monitoring response to treatment and minimal residual disease for solid tumors will eventually run on the Illumina NextSeq 550Dx.
While some groups have communicated their concerns directly to the agency, stakeholders have also formed a new coalition to publicly take issue with FDA's actions.
The Columbia Solid Tumor Panel, a custom NGS panel from Pillar Biosciences, will be used at CUMC's Laboratory of Personalized Genomic Medicine.
How labs — including those that are part of other healthcare systems — offering PGx testing will react to Inova's decision to not engage with the FDA remains to be seen.
Pharmacogenetics and legal experts took particular issue with the agency's suggestion that "established" drug/gene relationships are found only in FDA-approved drug labels.
The Washington Post reports on researchers' efforts to determine the effect of an increasingly common SARS-CoV-2 mutation.
Florida Politics reports Florida's law barring life, long-term care, and disability insurers from using genetic information in coverage decisions went into effect at the beginning of July.
A new analysis finds a link between popular media coverage of a scientific study and how often that paper is cited.
In Nature this week: CRISPR approaches to editing plant genomes, way to speed up DNA-PAINT, and more.