FDA grants emergency use authorisation for Abbott’s Covid-19 test

19 March 2020 (Last Updated March 20th, 2020 14:15)

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for Abbott’s molecular test for coronavirus (Covid-19).

FDA grants emergency use authorisation for Abbott’s Covid-19 test
Abbott scientists and engineers prepare coronavirus test kits for shipment. Credit: Abbott.

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The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for Abbott’s molecular test for coronavirus (Covid-19).

The molecular tests are run on the company’s m2000 RealTime System, a molecular solution with a broad range of tests.

Following the EUA, Abbott is shipping 150,000 RealTime SARS-CoV-2 tests to existing customers in the US.

Abbott chairman and CEO Miles White said: “A global challenge like coronavirus requires the commitment and cooperation of everyone who has the ability to help address it.

“I am proud of the Abbott team and what they have 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 platform uses polymerase chain reaction (PCR) technology, which amplifies a single piece or few copies of a piece of DNA to diagnose a patient with precision and speed.

It is currently used in hospital and reference labs in many parts of the world and is said to have the ability to run high volumes of up to 470 tests in 24 hours.

Abbott said it will coordinate with health systems and government authorities to deploy additional m2000 RealTime Systems to meet the demands for Covid-19 tests.

The company will also increase the production of the tests to highest levels possible at its US manufacturing location.

Earlier this month, it received CE Mark for the FlexNav delivery system for its Portico transcatheter aortic valve implantation (TAVI) system.

Meanwhile, the number of Covid-19 cases is growing around the world. The death toll has increased to 8,809 on 18 March.