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May 13, 2020

Abbott’s Covid-19 test secures EUA for use on Alinity System

Abbott has received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its Covid-19 molecular test for use on its new Alinity m molecular lab system.


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Abbott has received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its Covid-19 molecular test for use on its new Alinity m molecular lab system.

It is the fifth Covid-19 test developed by the company to receive FDA EUA.

Abbott is currently in the process of rolling out Alinity m molecular laboratory instrument to its US customers. The company is also working with hospitals and health systems in the country to install the new instrument that will help meet the growing demand for testing.

In March, the Alinity m system was cleared by the FDA for use with Abbott’s hepatitis C (HCV) assay.

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Considered to be the company’s advanced laboratory molecular instrument, the automated platform provides laboratories with improved efficiency and flexibility by running more tests in less time.

Abbott president and CEO Robert Ford said: “Molecular lab tests play a critical role in detecting the virus for Covid-19. As a leader in diagnostics, we are pushing forward to develop high-performing tests across our platforms to help combat this pandemic.

“As we continue to develop and improve our testing technologies, we want to ensure they are meeting the needs of our customers and right now that means having reliable tests for Covid-19 on all of our diagnostic instruments.”

Up to 1,080 tests can be run on the Alinity m system in 24 hours, while the company’s m2000 RealTime system runs around 480 tests in the same time period.

Furthermore, the system provides labs with true random access, enabling them to run any test, any time for multiple infectious diseases while still delivering results within two hours.

It is especially critical during the Covid-19 pandemic when volume, speed and flexibility are needed, the company noted.

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