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FDA Tells Testing Firm to Stop Sale of Unauthorized COVID-19 At-Home Kit

NEW YORK ─ The US Food and Drug Administration has issued a warning letter to Anytime COVID Test concerning the sale of its COVID-19 Test Kit to consumers for at-home use.

Anytime COVID's website promotes a test that provides results in 15 minutes or less in the privacy of the home without waiting for lab results. As of Wednesday, Anytime COVID was still advertising the blood-based test on its site.

The FDA said that it had not approved, cleared, or authorized marketing of the test and requested that the firm "take immediate action to cease the sale" of its product.

In its letter dated April 13 and posted on the FDA's website on Tuesday, the FDA's Center for Devices and Radiological Health said the test did not have an approved application for premarket approval or investigational device exemption. Further, the test is misbranded because Boynton Beach, Florida-based Anytime COVID had not notified the agency of its intent to distribute the device, the FDA said.

The agency noted that specimen collection and testing in the home rather than in a healthcare setting presents "different and potentially serious public health risks," which may include whether a layperson has the ability to collect the specimen, run the test, and accurately interpret the test result.