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March 19, 2020updated 20 Mar 2020 2:15pm

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

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


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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.

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Navigate your business through the ‘new normal’

COVID-19 continues to dominate headlines the world over. It has already affected our lives forever. The way we work, shop, eat, seek medical advice, and socialize will all be different in the future. Quite how different remains to be seen, but all industries must plan for multiple eventualities.  Faced with an explosion of conflicting information on how to plan and implement successful recovery strategies, decision-makers are in dire need of a single, reliable source of intelligence.   GlobalData’s COVID-19 Executive Briefing gives you access to unparalleled data and insights to successfully navigate the uncertain road to recovery across the world’s largest industries. Understand every aspect of this disruptive theme by delving into: 
  •  COVID-19 infection update, with statistics on the spread, testing by country, as well as the latest data on vaccines and therapeutic developments 
  • Economic impact overview, covering stock market indices, GDP, unemployment rates, policy responses & GlobalData’s economic recovery scorecards 
  • Sector developments, with access to sector insight summaries, cross-sector indices and the leaders and laggards in each industry vertical 
Whatever your company’s imminent strategic plans, the long-lasting impact of COVID-19 must not be overlooked. Find out how to futureproof your business operations – download our report today. 
by GlobalData
Enter your details here to receive your free Report.

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