20 March 2020 | News
The test will be used on the company's m2000 RealTime system that is currently available in hospitals and molecular laboratories in the U.S
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."
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.