Did BodySphere jump the gun on '2-minute' COVID-19 test?
April 3, 2020 -- The news seemed too good to be true: A company called BodySphere claimed to have received emergency use authorization from the U.S. Food and Drug Administration for what it said was a two-minute serological test for detecting COVID-19.  Discuss
FDA issues emergency authorization for BD, BioGX's COVID-19 test
April 3, 2020 -- The U.S. Food and Drug Administration (FDA) has granted an emergency use authorization to Becton Dickinson (BD) and BioGX for their novel coronavirus test.
Ipsum gets FDA nod for COVID-19 test
April 3, 2020 -- Ipsum Diagnostics has received emergency use authorization from the U.S. Food and Drug Administration (FDA) for its IDx diagnostic test to identify individuals with SARS-CoV-2, the virus that causes the respiratory disease COVID-19.
Quest ramps up coronavirus testing amid reports of backlog
April 2, 2020 -- Quest Diagnostics said it is ramping up its coronavirus testing capability to 30,000 tests per day, while stressing that cases will need to be prioritized in light of very high demand. The announcement came amid news media reports claiming that the company is partly to blame for a big backlog of tests reported in California.  Discuss
Cellex gets FDA authorization for COVID-19 antibody test
April 2, 2020 -- The U.S. Food and Drug Administration (FDA) has granted the first emergency use authorization for a test to determine COVID-19 status from antibodies in blood samples to the biotechnology company Cellex.
FDA provides reference sequence data for SARS-CoV-2
April 1, 2020 -- The U.S. Food and Drug Administration (FDA) has collaborated with four expert entities to develop quality-controlled sequence data for the SARS-CoV-2 reference strain.
Sectra gets FDA nod for digital pathology module
April 1, 2020 -- Digital image management developer Sectra has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its digital pathology module.
NeuMoDx coronavirus test gets emergency authorization
April 1, 2020 -- NeuMoDx Molecular's assay for SARS-CoV-2 has received an emergency use authorization from the U.S. Food and Drug Administration.
Siemens wins FDA clearance for blood gas analyzer
March 31, 2020 -- Siemens Healthineers has garnered U.S. Food and Drug Administration (FDA) clearance for its RapidPoint 500e blood gas analyzer.
Ga. man arrested for COVID-19 testing scheme
March 31, 2020 -- U.S. authorities have arrested a man from Georgia for running a company that allegedly received kickbacks for referring patients to clinical labs for diagnostic tests -- including COVID-19 tests.