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LDTs

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.

Shift in Regulation

An announcement last week says laboratory-developed tests do not need to undergo premarket review by FDA.

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.

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The sponsors of the VALID Act say it's time to modernize outdated diagnostic regulations slowing down test access during a public health crisis.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. 

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Novavax has begun a phase III trial of its SARS-CoV-2 vaccine, according to the New York Times.

Vox reports that the Trump Administration may limit student visas for individuals from some countries to two years.

The governor of New York says the state will conduct its own review of any SARS-CoV-2 vaccine, NPR reports.

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