Abbott’s RealTime SARS-CoV-2 Test Receives EUA

Abbott received Emergency Use Authorization (EUA) from the U.S. FDA 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 as needed.

The Abbott m2000 RealTime System 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 systems have the ability to run high volumes of up to 470 tests in 24 hours.

“A global challenge like coronavirus requires the commitment and cooperation of everyone who has the ability to help address it,” said Miles D. White, chairman and chief executive officer, Abbott. “I’m proud of the Abbott team and what they’ve accomplished in such a short period of time, and I want to thank the Administration and the FDA for their partnership in making this happen.”