LexaGene Responds to Demand for Better Diagnostics for COVID-19
LexaGene has done in-house testing on its LX Analyzer using the CDC’s coronavirus test, and the company is also developing tests of its own for SARS-CoV-2.
Read More
Search Results for: covid-19
HHS Supports Development of High-Throughput Molecular Diagnostic for COVID-19
A COVID-19 diagnostic designed for use on a system that can process up to 1,000 tests in 24 hours will receive advanced development support from an HHS BARDA grant.
Read MoreDiaSorin Molecular Receives BARDA Funding to Develop a Rapid COVID-19 Test
The product is expected to be CE marked and submitted to the FDA by the end of March 2020 to consider for emergency use authorization.
Read More
COVID-19: FDA Gives Flexibility to New York State Department of Health, Issues Emergency Use Authorization for Roche Diagnostic
FDA has exercised enforcement discretion to give the New York State Department of Health permission to authorize lab testing for COVID-19.
Read MoreFDA Confers Emergency Use Authorization on Roche’s Cobas SARS-CoV-2 Test
The test is intended for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19 disease, in nasopharyngeal and oropharyngeal swab samples from patients who meet COVID-19 clinical and/or epidemiological criteria for testing.
Read More