FDA Grants Marketing Authorization for Cue Health COVID-19 At-Home Molecular Test
The nucleic acid amplification test is the first at-home, over-the-counter test for COVID-19 to be granted marketing authorization using the traditional premarket review pathway.
Avacta Acquires Coris Bioconcept in Deal Potentially Worth £10.4M
Avacta said the deal for Coris is part of an M&A-focused strategy for expanding its diagnostics portfolio and gaining routes into testing markets.
The agency is cross-training employees to add surge capacity in response to shifting demand and is helping develop a pending national testing plan.
BioTeke Nabs FDA EUA for COVID-19 Rapid Antigen Test
The Bio-Self COVID-19 Antigen Home Test is a lateral flow immunoassay that uses nasal swab samples and delivers results in 15 minutes.
Domus Diagnostics Wins $2.4M NIH RADx Tech Contract
The firm will use the funding to validate a rapid, low-cost, zero-power multiplex assay for COVID-19, flu A and B, and respiratory syncytial virus.