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.
MicroGenDX offers 24-hour coronavirus test of saliva and sputum samples
April 3, 2020 -- MicroGenDX is offering a real-time reverse transcription polymerase chain reaction test to detect the novel coronavirus in saliva and sputum samples.
Siemens debuts test kit for COVID-19
April 3, 2020 -- Siemens Healthineers has created a fast-track diagnostics test kit to help identify patients with COVID-19.
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.
Henry Schein to distribute COVID-19 rapid test kit
April 1, 2020 -- Henry Schein has become the exclusive U.S. distributor of a second point-of-care rapid test kit for the novel coronavirus.
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.
Molecule Holdings launches COVID-19 antibody test
April 1, 2020 -- Molecule Holdings is rolling out its COVID Care immunoglobulin G/immunoglobulin M COVID-19 rapid test kits for medical professionals, first responders, and law enforcement.
BioIQ readies COVID-19 saliva test
April 1, 2020 -- Healthcare engagement and technology platform firm BioIQ announced that its saliva-based COVID-19 test will be available as soon as next week.