Test that detects coronavirus, flu will get FDA emergency use authorization, firm says


The medical know-how firm behind a molecular diagnostic take a look at that may detect each the influenza virus and coronavirus in a bit of as two to 3 hours stated it obtained Emergency Use Authorization from the FDA on Friday.

Becton, Dickinson and Company (BD), stated its take a look at, which runs on the corporate’s present BD Max platform, can also be able to detecting the U.Okay. and South African coronavirus variants with 99.9% accuracy.  

“A pc evaluation confirmed that 99.9% of the genetic sequences of those variants are an an identical match to no less than one of many two molecular targets for the take a look at,” the corporate stated in a information launch. “This skill to detect these new variants additionally applies to the standalone SARS-CoV-2 take a look at for the BD Max System.”

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The take a look at, which additionally detects influenza A and B strains, gives a constructive or detrimental consequence for every virus utilizing a single specimen. The firm stated 1000’s of laboratories worldwide are already utilizing the BD Max System diagnostic platform, and that every unit is ready to analyze lots of of samples over a 24-hour interval.

“Our diagnostic options for COVID-19 and Flu will assist inform well timed analysis and, in the end, could contribute to sooner and clinically acceptable affected person administration and therapy,” stated Dave Hickey, president of Life Sciences for BD, in a information launch. “In addition, the brand new info offered on the take a look at’s skill to detect the U.Okay. and South African variants gives useful steering to well being care practitioners as we glance to establish and comprise these new strains.”

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The firm stated it additionally obtained a CE mark, which signifies approval within the European Union.



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