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The community is poised to be the primary channel for stakeholders to communicate PGx concerns with FDA, but it is unclear if all stakeholders will participate.
The move raises questions about what precisely is an LDT outside of FDA jurisdiction and heightens concerns that poorly validated tests will enter the market and endanger public health.
The action will immediately allow labs to offer SARS-CoV-2 LDTs without requiring EUA, and make it voluntary for labs to take LDTs through FDA premarket review.
The company has issued a call for the 2,500 independent MDx labs across the US to join together in an effort to double SARS-CoV-2 testing capacity.
The VITAL Act strikes a counterpoint to another bipartisan-backed bill, called VALID, that would give FDA oversight responsibilities over all clinical tests, including LDTs.
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The sponsors of the VALID Act say it's time to modernize outdated diagnostic regulations slowing down test access during a public health crisis.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.