Accelerate Diagnostics Announces FDA Emergency Use Authorization for COVID-19 Antibody Testing System

TUCSON, Ariz., Aug. 18, 2020 /PRNewswire/ — Accelerate Diagnostics, Inc. (NASDAQ: AXDX) and BioCheck, Inc., a privately-held San Francisco-based company focused on in vitro diagnostics, today announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the BioCheck SARS-CoV-2 IgM and IgG Combo Test and fully-automated MS-Fast instrument.Continue reading

Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization to Yale School of Public Health for SalivaDirect, Which Uses a New Method of Saliva Sample Processing

FDA, August 15, 2020:  Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) to Yale School of Public Health for its SalivaDirect COVID-19 diagnostic test, which uses a new method of processing saliva samples when testing for COVID-19 infection.Continue reading

Sanofi and GSK selected for Operation Warp Speed to supply United States Government with 100 million doses of COVID-19 vaccine

  • Promising vaccine candidate selected by U.S. government’s Operation Warp Speed
  • U.S. government to provide funding up to $2.1 billion for development including clinical trials, manufacturing, scale-up and delivery of an initial 100 million doses
  • Ongoing discussions with European Commission – with France and Italy on the negotiation team – and other governments to ensure global access to a novel coronavirus vaccine
  • Sanofi and GSK today announce a collaborative effort with the U.S. government to accelerate the development and manufacturing of a COVID-19 recombinant protein-based vaccine.

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