FDA Warns Against At-Home COVID-19 Testing Kits

A number of startups announced they would begin selling at-home COVID-19 testing kits this week. These startups included:  Carbon Health, a tech-enabled healthcare network that combines virtual and in-person care, Everlywell, a company that offers food sensitivity and various other home health tests, and Nurx, an app that delivers prescriptions and STI testing kits.

But the U.S. Food and Drug Administration (FDA) quickly responded, demonstrating that it is actively and aggressively monitoring the market for products with fraudulent COVID-19 claims, as we previously reported here.

In its March 20 statement, FDA directly warned consumers—and indirectly warned the startups—that it “has not authorized any test that is available to purchase for testing yourself at home for COVID-19.” In other words, it “is beginning to see unauthorized fraudulent test kits that are being marketed to test for COVID-19 in the home.” FDA suggested that the public health value of expanded COVID-19 testing is predicated on testing that is “safe and accurate.”

FDA also clarified its Policy for Diagnostic Tests for Coronavirus Disease-2019. The policy was published on February 29, and updated on March 16, to expedite the availability of diagnostic tests. The policy describes the circumstances under which laboratories that develop and validate tests for coronavirus can use the tests before FDA has completed review of their Emergency Use Authorization (EUA). The policy only applies to laboratories that are certified to perform high-complexity testing consistent with requirements under Clinical Laboratory Improvement Amendments (CLIA).

However, in an FAQ section, FDA clarified that it is not blessing at-home COVID-19 testing kits—even if they are developed by a CLIA-certified lab. Instead, FDA “encourage[d] developers to discuss their validation of home use and/or self-collection tests with [the agency] early in their development process.” Test developers and laboratories who have questions about the EUA process can contact FDA’s 24-hour toll-free phone line.

The Morrison & Foerster COVID-19 Task Force will continue to provide updates as the FDA issues guidance for consumer-facing product manufacturers.