Novel Coronavirus (COVID-19) Updates
FDA Approves First Rapid Point-Of-Care COVID-19 Diagnostic Test
Sunnyvale-based molecular diagnostic company Cepheid received FDA approval for the first rapid coronavirus test with a 45-minute detection time. This test will be used primarily in hospitals and emergency rooms.
Abbott receives FDA Emergency Use Authorization and Launches Test to Detect Novel Coronavirus
Abbott has received FDA emergency use authorization for a molecular test for novel coronavirus (COVID-19). The Abbott m2000 RealTime System is a molecular solution featuring a broad menu of tests, including ones for infectious diseases. The platform uses polymerase chain reaction (PCR) technology, which amplifies a single piece (or few copies of a piece) of DNA to quickly and accurately diagnose a patient. The m2000 is currently used in labs around the world.
Roche begins shipments of first 400,000 COVID-19 tests to laboratories across the US to begin patient testing under FDA Emergency Use Authorization
Roche plans to ship an additional 400,000 tests per week to the laboratory testing sites across the nation that are set up to run the test immediately under the guidelines of the FDA Emergency Use Authorization (EUA). The Cobas SARS-CoV-2 Test provides reliable and high-quality results for clinical decision-making for the improved management of COVID-19 patients and to reduce the risk of SARS-CoV-2 (coronavirus) infection. These highly automated tests provide results in 3-½ hours.
Eli Lilly teams with Indiana Health Agency to provide speedy Coronavirus Testing to Indiana Residents
Eli Lilly teams with the Indiana State Department of Health (ISDH) to rapidly expand and accelerate testing for the SARS-CoV-2 coronavirus in Indiana.
Thermo Fisher plans to produce up to 5 million of a new test to detect the Novel Coronavirus
Thermo Fisher, the largest maker of scientific tools, plans to produce up to 5 million of a new test to detect the novel coronavirus that causes Covid-19. The Food and Drug Administration granted the new test an emergency use authorization status.
*Emergency Use Authorization (EUA): Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives.