Abbott gets USFDA emergency use authorization for COVID-19 molecular test

Abbott Park, Ill: Abbott has announced that the U.S. Food and Drug Administration 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.

"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."

Abbott is working to do its part to combat this global pandemic. Across the U.S., more than 175 m2000 systems are used in hospital and reference laboratories. The systems have the ability to run high volumes of up to 470 tests in 24 hours, helping to meet the increasing demand for testing.

Many of these instruments are used in university and community hospitals where patients come for care, resulting in testing that happens closer to the patient rather than sending it to an offsite lab. Abbott is immediately distributing 150,000 tests and will continue ramping up production to the highest levels possible, with the goal of providing up to 1 million tests per week. Abbott is manufacturing these tests in the U.S.

Read also: Abbott Bags European Nod For Tendyne Transcatheter Mitral Valve Implantation System

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 a few copies of a piece) of DNA to quickly and accurately diagnose a patient. The m2000 is currently used in labs around the world.

Read also: Abbott Introduces Next-Generation Heart Rhythm Management Devices In Europe