LDTs

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.

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. 

The Columbia Solid Tumor Panel, a custom NGS panel from Pillar Biosciences, will be used at CUMC's Laboratory of Personalized Genomic Medicine.