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Abbott Receives FDA Emergency Use Authorization for COVID-19 Test

MAR 18, 2020 | MICHAELA FLEMING
The US Food and Drug Administration (FDA) has issued Emergency Use Authorization for Abbott’s molecular COVID-19 test.

In response to the authorization the company announced that 150,000 of the Abbott RealTime SARS-CoV-2 tests are being shipped within the United States. Tests have already been sent to facilities in 18 states including New York and Washington where the majority of US COVID-19 cases have been recorded.

The tests are utilized on the m2000 RealTime System, a platform which uses polymerase chain reaction technology for rapid diagnosis. More than 175 m2000 systems are used in hospital and laboratories across the United States.

According to Abbott, the systems can run high volumes of up to 470 tests in 24 hours.

The company will also be scaling up production to manufacture 1 million tests per week by the end of March.

"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 in the announcement. "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."
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