Close Menu

LDTs

Adaptive Cofounder and Chief Scientific Officer Harlan Robins compared the launch of the test to the unveiling of the Tesla Roadster electric sports car.

A new GeoMx Digital Spatial Profiler assay will have up to 30 protein targets and will be validated for potential use as a laboratory-developed test.

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The sponsors of the VALID Act say it's time to modernize outdated diagnostic regulations slowing down test access during a public health crisis.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

Pages

Politico reports that the NYPD DNA database has grown since it announced it would be removing profiles from it.

Forbes reports that a structural biology lab at Oxford University studying the coronavirus was hacked.

Science reports that a Dutch research funding agency is combating a ransomware attack.

In Science this week: set of 64 haplotype assemblies from 32 individuals, and more.