FDA grants emergency use authorization for 5-13 minute Covid-19 test

Abbott has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the fastest available molecular point-of-care test for the detection of novel coronavirus (COVID-19), delivering positive results in as little as five minutes and negative results in 13 minutes.

What makes this test so different is where it can be used: outside the four walls of a traditional hospital such as in the physicians' office or urgent care clinics.

The new Abbott ID NOW COVID-19 test runs on Abbott's ID NOW^TM platform—a lightweight box (6.6 pounds and the size of a small toaster) that can sit in a variety of locations.

Because of its small size, it can be used in more non-traditional places where people can have their results in a matter of minutes, bringing an alternate testing technology to combat the novel coronavirus.

We're ramping up production to deliver 50,000 ID NOW COVID-19 tests per day, beginning next week, to the U.S. healthcare system.

This comes on the heels of our announcement last week of the availability of the Abbott RealTime SARS-CoV-2 EUA test under FDA EUA, which runs on m2000 RealTime molecular system for centralized lab environments. Combined with ID NOW, Abbott expects to produce about 5 million tests in April.

Testing remains a crucial step in controlling the novel COVID-19 pandemic. Continuing to supply healthcare providers with new technologies to help curb the spread of infection is a top priority for public health officials and healthcare providers.

Taking molecular testing to the front lines
Molecular point-of-care testing for COVID-19 offers healthcare workers rapid results in more settings where people show up for care. Molecular testing technologies help detect the presence of a virus by identifying a small section of the virus' genome, then amplifying that portion until there's enough for detection. This process can cut testing wait time from hours, if not days, to as little as five minutes for positive results and 13 minutes for negative results.

When not being used for COVID-19 testing, ID NOW is the leading molecular point-of-care platform for Influenza A&B, Strep A and respiratory syncytial virus (RSV) testing. Our platform holds the largest molecular point-of-care footprint in the U.S. and is already widely available in physicians' offices, urgent care clinics, and hospital emergency departments across the country.

"Through the incredible work of teams across Abbott, we expect to deliver 50,000 COVID-19 tests per day to healthcare professionals on the front lines, where testing capabilities are needed most," said Chris Scoggins, senior vice president, Rapid Diagnostics, Abbott. "Portable molecular testing expands the country's capacity to get people answers faster."

The ID NOW COVID-19 EUA has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories and patient care settings. The test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

 

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