Luminex secures EUA for SARS-CoV-2 assay
April 6, 2020 -- Luminex has secured an emergency use authorization (EUA) from the U.S. Food and Drug Administration for its Aries SARS-CoV-2 assay.
Gladstone Institutes launches COVID-19 fund
April 6, 2020 -- Gladstone Institutes is seeking donations to mobilize resources and start research projects to help fight the COVID-19 pandemic.
Natera's prenatal testing coverage expands
April 6, 2020 -- A national insurer has expanded coverage of Natera's Panorama cell-free DNA and noninvasive prenatal test to all pregnant women, regardless of age. Natera did not name the insurer.
Biotecon plans to distribute SARS-CoV-2 test globally
April 6, 2020 -- Biotecon Diagnostics announced that it is planning for the distribution of its SARS-CoV-2 polymerase chain reaction detection test worldwide.
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.