The FDA yesterday informed Cellex that it is issuing emergency use authorization (EUA) for the company’s SARS-CoV-2 antibody test for detecting coronavirus. Cellex (Research Triangle Park, N.C.) is touting its rapid test as the first of its kind to receive authorization amid the coronavirus crisis. It is a lateral flow immunoassay designed for the qualitative […]
Siemens Healthineers seeking EUA for its coronavirus test kit
Siemens Healthineers (ETR: SHL) announced today that it is making its Fast Track Diagnostics (FTD) test kit for COVID-19 available as it seeks FDA emergency use authorization (EUA) and other forms of regulatory approval. The FTD SARS-CoV-2 assay kit is designed to diagnose infection by the SARS-CoV-2 virus that causes coronavirus. Siemens Healthineers is already shipping test […]
BD to launch point-of-care COVID-19 antibody test
Becton Dickinson (NYSE:BDX) yesterday announced a new point-of-care test that can detect antibodies in blood to confirm current or past exposure to COVID-19 in as little as 15 minutes. The new test, developed and manufactured by BioMedomics (Morrisville, N.C.), will be available through BD and distributed exclusively by Henry Schein (NSDQ:HSIC) to healthcare providers throughout the […]
Chembio, Molecule Holdings launch fingerstick COVID-19 tests
Chembio Diagnostics and Molecule Holdings announced the launch of their separate COVID-19 serological point-of-care tests for detecting antibodies associated with coronavirus. Chembio’s fingerstick-style test using its MicroReader 1 and MicroReader 2 analyzers is designed to detect IgM and IgG antibodies and offer results within 15 minutes, according to a news release. Chembio (Medford, N.Y.) said […]
FDA authorizes Bodysphere 2-minute COVID-19 test
Update: Bodysphere issued a statement clarifying that, in the rush to get its kits on the front lines, it misinterpreted the test’s listing on the FDA registry website. The test has not yet been cleared by the FDA. Bodysphere announced today that it has begun distributing its 2-minute testing kit for diagnosing COVID-19 after receiving […]
Abbott launches five minute rapid COVID-19 test
Abbott (NYSE:ABT) announced that it received FDA emergency use authorization (EUA) for what it touts as the fastest available molecular point-of-care test for detecting COVID-19. The test, which Abbott says can deliver positive results in as little as five minutes and negative results in 13 minutes, is slated to run on the company’s ID Now platform […]
Mologic starts validation of point-of-need coronavirus test
Mologic announced today that it initiated early validation of point-of-need COVID-19 diagnostic tests with two United Kingdom-based universities. The Bedfordshire, U.K.-based company is initiating its tests with the Liverpool School of Tropical Medicine and St. George’s University London, according to a news release. The accelerated development of the test is a product of funding from […]
Thermo Fisher lines up financing for Qiagen buy
Thermo Fisher Scientific (NYSE:TMO) confirmed in a prospectus supplement that it is in part financing its $11.5 billion purchase of Qiagen (NYSE:QGEN) with an offering worth $2.2 billion. The offering includes $1.1 billion in 4.133% senior notes due in 2025 and another $1.1 billion in 4.497% senior notes due in 2030. Thermo Fisher said in its prospectus […]
SGI-DNA touts its automated gene printer for coronavirus vaccine development
Synthetic biology company SGI-DNA is touting its efforts to accelerate research in the creation of vaccines for SARS-CoV-2, the virus causing the COVID-19 pandemic. The San Diego-based company said in a news release last month that it built the genes thought to be critical to developing successful vaccines against the virus and made those tools available as […]
Cepheid wins emergency use nod from FDA for bedside coronavirus test
Danaher Corp. (NYSE:DHR) subsidiary Cepheid announced that it received emergency use authorization from the FDA for its bedside Xpert Xpress SARS-CoV-2 test for detecting the virus causing the COVID-19 outbreak. The rapid molecular diagnostic test is designed to detect the SARS-CoV-2 virus causing coronavirus while operating on any of Cepheid’s GeneXpert systems worldwide, with a detection […]
Lucence, Carbon Health tout COVID-19 test kits
Singapore-based Lucence said it has developed a sample collection device for viral infections such as COVID-19. Unlike other companies’ tests, Lucence’s SAFER-Sample (Stabilization of nucleic Acid Formulation for Evaluation of RNA) does not require samples from nose or throat swabs to be chilled for transport to a lab, according to the company. It comes with […]
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