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FDA Warns Firms About Improper Sale of SARS-CoV-2 Antibody Tests

NEW YORK – The US Food and Drug Administration said on Wednesday that it has issued warning letters during the past week to three companies for improperly selling SARS-CoV-2 antibody tests directly to the public for at-home use.

The letters were sent to Medakit, based in Hong Kong; and Yama Group of the United Arab Emirates; and Jason Korkus and Sonrisa Family Dental, doing business as, in Chicago.

The FDA accused each of selling antibody tests for detecting COVID-19, the disease caused by SARS-CoV-2, directly to consumers for at-home use without proper regulatory clearance, approval, or authorization from the agency. Sonrisa sold a test – the Cellex Test Kit from Cellex – that received Emergency Use Authorization from the FDA in April. However, the test received EUA for use only in laboratories certified under CLIA to perform moderate- and high-complexity tests.

"To date, FDA has not approved, cleared, or authorized any COVID-19 serology test for at-home testing," the agency said in its letters to the three companies. The FDA has authorized some sample collection kits for coronavirus testing for use in the home of patients, but no test, antibody-based or molecular, has been authorized for at-home use from start to finish that includes the actual running of the test.

The agency has requested the three firms to immediately correct the violations, including stopping the sale of the products or preventing future sales, or face possible legal action, such as seizure and injunction.

In a statement, the agency noted that the three letters are the first it has sent for marketing adulterated or misbranded test kits for the coronavirus. Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, said that the FDA will continue to monitor tests marketed in the US and take appropriate action as required.

The warning letters, combined with the revocation this week of an EUA previously issued to Chembio Diagnostics, may signal increased vigilance on the FDA's part against firms offering coronavirus antibody tests that it believes could harm consumers. On Tuesday, the FDA revoked the EUA originally issued for Chembio's SARS-CoV-2 antibody test in April, saying it found problems with the test's performance.

Since the FDA put in place mechanisms allowing antibody tests for the coronavirus to be marketed, it has faced a Sisyphean task overseeing and regulating them. Some test makers deemed the FDA's original guidance for the tests confusing.

Others said that one pathway for getting antibody tests to market, called Policy D, led to a wave of junk tests that flooded the market. Under Policy D test makers could distribute coronavirus serology tests simply by telling the agency in an email of their intention to do so and by providing cursory validation data and certain product labeling. 

In early May, the FDA sought to address the problem by effectively shutting down the Policy D pathway. Companies that want to market their SARS-CoV-2 antibody tests now have to seek EUA, and the tests have to meet certain performance thresholds. A little more than two weeks after the new guidance was announced, the FDA removed more than two dozen tests from the list of SARS-CoV-2 serology assays that had been marketed by their manufacturers under Policy D. 

To date, 20 serology tests have been issued EUAs by the FDA.