U.S. Approves Abbott Labs Coronavirus Test For Hospital Use

Abbott Laboratories won U.S. approval for its molecular test for the Coronavirus strain COVID-19, which will be used by hospitals and academic medical centers to speed diagnostic capabilities for the disease sweeping across the country.

The "emergency use authorization" from the U.S. Food and Drug Administration allows Abbott to begin shipping 150,000 laboratory tests immediately, the company said Wednesday. The tests are run on Abbott’s "m2000TM RealTime System," which is already located in more than 175 U.S hospitals and academic medical centers.

Abbott has an established history in the development of diagnostic tests, particularly for infectious diseases like the AIDS virus and its system is known globally among researchers, hospitals and academic medical centers as the developer of the first HIV test.

"A global challenge like coronavirus requires the commitment and cooperation of everyone who has the ability to help address it," Abbott chairman and chief executive Miles White said in a statement. "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 FDA’s approval of Abbott’s test comes as the Trump administration and federal agencies have been criticized for the lack of testing for Coronavirus. The U.S. is considered well behind other countries when it comes to the availability of testing generally.

Abbott said the company will begin scaling up production at its U.S. manufacturing plant "to reach capacity for 1 million tests per week by end of March." Abbott said its systems have "the ability to run high volumes of up to 470 tests in 24 hours, helping to meet the increasing demand for testing."

And more companies that make diagnostic tests are coming online and working to quickly ramp up testing for Coronavirus. Earlier this week, Becton Dickinson  submitted an emergency request to the FDA with molecular diagnostic firm BioGX to increase capacity of tests for the Coronavirus strain COVID-19.

Becton Dickinson rival Roche, which already received an emergency approval for the first U.S. approved test for Coronavirus strain COVID-19, said it began shipping an initial 400,000 test kids Friday.

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