Abbott accelerates test launch to combat the COVID-19 pandemic

MedTech News: Abbott announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorisation (EUA) for the company’s molecular test for novel coronavirus (COVID-19).

Abbott’s Asia Pacific office told Health Industry Hub “We are ramping up our manufacturing capacity. We will communicate country-specific plans as they are determined.”

Abbott is immediately shipping 150,000 Abbott RealTime SARS-CoV-2 EUA tests to customers in the U.S. The tests are used on the company’s m2000™ RealTime System.

“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.”

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The m2000 Molecular Platform has the ability to run high volumes of up to 470 tests in 24 hours, helping to meet the increasing demand for testing. Many of these instruments are used in university and community hospitals where patients come for care, resulting in testing that happens closer to the patient rather than sending it to an offsite lab.

Abbott will continue ramping up production to the highest levels possible, with the goal of providing up to 1 million tests per week. Abbott is manufacturing these tests in the U.S.