IDT
FDA-Led Group Evaluates Performance of RUO Liquid Biopsy Assays to Inform Practice Guidelines
Premium
The researchers found that the reliable sampling of rare circulating tumor DNA fragments served as the key challenge for developing liquid biopsy assays.
Clear Labs, Integrated DNA Technologies Expand Partnership to Include COVID-19 Testing
The collaboration builds on an oligonucleotide supply agreement the partners signed in 2019 for Clear Labs' nanopore sequencing-based food safety testing.
Helix Gets FDA Emergency Use Authorization for NGS-Based COVID-19 Test
The in vitro diagnostic test runs on the Illumina NovaSeq 6000 instrument and will be performed at Helix's San Diego CLIA-certified laboratory.
Sherlock Biosciences, IDT Collaborate to Manufacture CRISPR-Based SARS-CoV-2 Testing Kits
Sherlock Bio recently received US Food and Drug Administration Emergency Use Authorization for the kit, which uses CRISPR to detect the virus in patient samples.
SARS-CoV-2 Experience Will Help Agency Strike Right Balance With LDTs, FDA Says
FDA officials said at ACLA's annual meeting that the agency's efforts to balance rapid test access with safety during the coronavirus crisis carries lessons for the oversight of all tests.