FDA OKs two COVID-19 tests from Ender November 25, 2020 -- The U.S. Food and Drug Administration (FDA) has approved two COVID-19 tests made by Ender Diagnostics North America, the U.S. subsidiary of the Swiss-based Ender Diagnostics.
Vaccines won't eliminate the need for COVID-19 testing November 24, 2020 -- The impending arrival of a vaccine for the SARS-CoV-2 virus is great news for a world weary of fighting the COVID-19 pandemic. But what effect will a vaccine have on lab testing for the novel coronavirus? Bruce Carlson of Kalorama Information explores this question. Discuss
IVD firms ready high-throughput antigen tests November 23, 2020 -- Antigen tests for COVID-19 are already an important component of testing for the disease. An antigen test reveals if a person is currently infected with a pathogen such as the SARS-CoV-2 virus. Bruce Carslon of Kalorama Information breaks down the products that are becoming available. Discuss
PerkinElmer receives CE Mark for SARS-CoV-2 assay November 20, 2020 -- PerkinElmer has received a CE Mark for its SARS-CoV-2 real-time reverse transcription polymerase chain reaction (RT-PCR) assay. Now, saliva can be designated as a specimen type and there is an option to pool up to five specimens collected from individuals suspected of COVID-19 -- including asymptomatic individuals.
FDA OK's new claim for Hologic's HIV assay November 20, 2020 -- The U.S. Food and Drug Administration (FDA) has approved Hologic's diagnostic claim for its HIV-1 viral load monitoring assay, the Aptima HIV-1 Quant Dx assay.
FDA issues EUA for 1st at-home COVID-19 self-test November 18, 2020 -- The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the first at-home COVID-19 self-test kit. The product was developed by Lucira and offers results within 30 minutes.