The COVID Crisis: FDA Provides Emergency Authorization For “Game-Changer” COVID-19 Test

​In an effort to slow the spread of the novel coronavirus from Harlem to Hollywood, the U.S. Food and Drug Administration (FDA) has been looking into a number of COVID-19 tests.

Most recently, the agency issued emergency authorization for use to Abbott’s ID NOW lab-in-a-box reports Consumer Affairs.

The test, which is as small as a toaster and works by scanning for a small segment of the SARS-CoV-2 virus, can let users know if they have COVID-19 in just a few 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,” Abbott wrote in an announcement. “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.”


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Providing rapid answers

Abbott said it has sped up production of the tests and expects to deliver 50,000 per day to the healthcare system starting next week.

“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,” Chris Scoggins, senior vice president, Rapid Diagnostics, Abbott said in a statement. “Portable molecular testing expands the country’s capacity to get people answers faster.”

In a statement, FDA Commissioner Steve Hahn said the tests could be a “game-changer” when it comes to diagnosing the virus and helping ensure that people receive prompt treatment.

“I am pleased that the FDA authorized Abbott’s point-of-care test yesterday. This is big news and will help get more of these tests out in the field rapidly,” FDA Commissioner Steve Hahn said in a statement. “We know how important it is to get point-of-care tests out in the field quickly. These tests that can give results quickly can be a game-changer in diagnosing COVID-19.”

In the midst of the current health crisis, the FDA has also given emergency authorization for use to California-based Cepheid, which offers a test that provides a positive or negative result within 45 minutes. Mesa Biotech has also received authorization for a small test to be used at temporary screening facilities and labs, which can give results in 30 minutes.

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