FDA Sends Warning Letters to Companies Improperly Marketing At-Home SARS-CoV-2 Antibody Tests

Federal agency notifies three companies about its concerns for “adulterated and misbranded” COVID-19 tests intended to be used by consumers at home.

In mid-June, the US Food and Drug Administration (FDA) issued warning letters to three separate companies for marketing “adulterated and misbranded” SARS-CoV-2 tests. The FDA stated its press release that these warning letters are the first set of letters that the agency has ever issued for misbranded and adulterated SARS-CoV-2 tests.

The FDA has come under criticism (see STAT COVID-19: FDA Acknowledges Tradeoffs of Early SARS-CoV-2 Serological Tests) for the relaxed regulation of SARS-CoV-2 testing, especially relating to its serology testing authorization. Initially, early in the COVID-19 public health emergency, the FDA issued relaxed rules that allowed manufacturers to market serology tests without an emergency use authorization (EUA). Manufacturers simply needed to notify the agency that their COVID-19 tests had been validated and that they contained certain disclaimers. On May 4, 2020, the FDA issued a more restrictive rule to require manufacturers currently marketing SARS-CoV-2 serology tests to apply for an EUA and released an EUA template for manufacturers to use.

Improper Actions of Manufacturers and Perceptions About At-Home COVID-19 Testing

Explaining why it issued warning letters to manufacturers, the FDA issued a press release. “Providing regulatory flexibility during this public health emergency never meant we would allow fraud,” stated Jeffrey Shuren, MD, JD, Director of the FDA’s Center for Devices and Radiological Health. “When tests are marketed inappropriately, with inaccurate or misleading claims—such as the ability to perform the test completely at home, or that the test is authorized, cleared, or approved when it is not—they put the health of Americans at risk. Such conduct will not be tolerated by the FDA, and we will continue to monitor tests marketed in the US, taking appropriate action as warranted.”

The three companies to receive warning letters included:

Medakit Ltd. of Sheung Wan, Hong Kong;
Antibodiescheck.com and Yama Group; and,
Dr. Jason Korkus, DDS, and Sonrisa Family Dental doing business as My COVID19 Club of Chicago, Illinois.

At-Home COVID-19 Test Marketing Violations Noted by the FDA

The specific violations outlined in the FDA’s warning letters included: “offering test kits for sale in the United States directly to consumers for at-home use without marketing approval, clearance, or authorization from the FDA; misbranding products with labeling that falsely claims products are ‘FDA approved’; and labeling that bears the FDA logo, which is only for the official use by the FDA and not for use on private sector materials.”

These cases involve serology testing and, with these actions, the FDA reinforced its position that it has not approved, cleared, or authorized any COVID-19 serology test for at-home testing (as of June 17).

Models Forming Toward At-Home COVID-19 Diagnostic Testing

On the other hand, diagnostic at-home testing for COVID-19 is beginning to take shape. In some cases, partnerships are forming community response approaches where healthcare professionals take the lead. In one instance, Ochsner Health in the greater New Orleans area is working with on-demand mobile healthcare service Ready to provide in-home visits and at home COVID-19 testing, according to a press release from Ready.

In other news, urgent care provider Remedy announced recently that it has expanded its services in Texas to provide “quick-dispatched house calls along with in-home COVID-19 testing.” Remedy states on its website that it will offer PCR (swab) and antibody tests.

These partnerships could be perceived to be in contrast with the “at-home lab testing kits,” such as that of the Everlywell COVID-19 Test Home Collection Kit, where consumers are pitched and then directed to contact their health insurer to see if the test will be covered or reimbursed, according to the company’s website. However, in Everlywell’s case, the FDA as of May 16, authorized Everlywell’s at-home sample collection kit “to be used by individuals at home who have been screened using an online questionnaire that is reviewed by a health care provider,” according to the FDA.

In its statements about the Everlywell COVID-19 test offering, the FDA stated that it also had authorized two COVID-19 diagnostic tests—performed at specific clinical laboratory companies—for use with samples collected using the Everlywell COVID-19 Test Home Collection Kit. “These tests have been authorized under separate, individual EUAs. Additional tests may be authorized for use with the Everlywell at-home collection kit in the future, provided data are submitted in an EUA request that demonstrate the accuracy of each test when used with the Everlywell at-home collection kit,” according to the FDA.

Laboratory Corporation of America (LabCorp) was the first diagnostic test developer to receive approval from the FDA to market an at-home specimen collection kit for COVID-19. In an April 21 FDA news release, the federal agency announced it had “re-issued the EUA for the Laboratory Corporation of America COVID-19 RT-PCR Test to permit testing of samples self-collected by patients at home using LabCorp’s Pixel by LabCorp COVID-19 Test home collection kit.” At the time, availability was limited but is now “available broadly” and has been expanded to “all individuals who meet the screening criteria for COVID-19 testing,” states LabCorp’s Pixel web page.

Similar developments paved the way for Quest Diagnostics to perform COVID-19 tests on samples self-collected at home. MedTechDive reports that Quest is working with direct-to-consumer company LetsGetChecked (which appears on the CVS Pharmacy home health testing hub).

At-Home Testing Warning Letters: Implications for Clinical Laboratories and Pathologists

Clinical pathologists have a unique understanding of the challenges that must be overcome for at-home self-collection for COVID-19 testing and of the potential for mishandling of specimens, which is inherent with at-home test kits.

However, the need for regulatory flexibilities in response to the SARS-CoV-2 outbreak may help the direct-to-consumer (DTC) lab testing market, at least in terms of access. More choices in COVID-19 at-home testing could create new sources of revenue for clinical laboratories. At the same time, at-home tests using specimens collected by consumers could complicate the risks for clinical labs, healthcare providers, and consumers as they deal with the SARS-CoV-2 pandemic.

The fact that the FDA is now sending warning letters to companies inappropriately marketing SARS-CoV-2 testing will be welcomed by clinical laboratories that perform testing using FDA-authorized methods. Not only will the FDA’s action inhibit fraud and the use of illicit COVID-19 tests, it may help increase consumer confidence in the quality of COVID-19 tests.