Nonprescription COVID-19 Test Approved by FDA

March 8, 2021 by Daniel Mollenkamp
FILE - In this March 1, 2021, file photo, a patient receives a shot of the Moderna COVID-19 vaccine next to a guidelines sign at a CVS Pharmacy branch in Los Angeles. More than 27 million Americans fully vaccinated against the coronavirus will have to keep waiting for guidance from U.S. health officials for what they should and shouldn’t do. The Biden administration said Friday, March 5, it’s focused on getting the guidance right and accommodating emerging science. (AP Photo/Marcio Jose Sanchez, File)

WASHINGTON – The Food and Drug Administration issued an emergency authorization for a non-prescription, over the counter nostril test for coronavirus, the agency announced on Friday. 

It’s the first over the counter molecular test they have authorized for use without a prescription. 

It’s also the latest in test and collection kits authorized by the FDA to track the virus. The FDA has authorized 330 such items in its rush to expand the testing capability and access in the U.S.

The test, Cue COVID-19 Test for Home and Over The Counter, which utilizes a nasal swab, can be used by adults and children over the age of two, the agency explained in a written statement. It offers results through a mobile app in about twenty minutes, and its track record is good. The test was able to identify 96% of positive samples from people showing symptoms and 100% from people with no symptoms, the agency reported. 

It received an emergency use authorization from the FDA, a designation which is allowed to expand access during a crisis. The agency says it has prioritized emergency use applications that would increase access to testing or testing capabilities, such as this one.

Data from Johns Hopkins University indicates that positive tests in the U.S. have been declining since January, with an average of about 4.2% coming back positive as of March 5th. According to materials published by the World Health Organization in May, a positive test rate of less than 5% is one possible indicator that a country has the epidemic under control. The total new number of tests in the country has increased since last summer. 

Acting FDA Commissioner Janet Woodcock said that the approval of this test is part of the agency’s continued effort to provide flexibility to test developers in order to speed up the availability of tests.

“The FDA will continue to expand Americans’ access to testing to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” she said.

The company that makes the test, Cue Health, told the agency that it intends to produce more than 100,000 tests per day by summer.

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