FDA issues emergency use authorisation for RealTime SARS-CoV-2 EUA test as diagnostic for coronavirus.- Abbott
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Published:20th Mar 2020
Abbott announced that the FDA has issued Emergency Use Authorization (EUA) for the company's molecular test for novel coronavirus (COVID-19). Abbott is immediately shipping 150,000 Abbott RealTime SARS-CoV-2 EUA tests to existing customers in the U.S. The tests are used on the company's m2000 RealTime System. Abbott will be working with health systems and government authorities to deploy additional m2000 systems where they are needed.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.