First Warning Letters Issued for Improper Marketing of SARS-CoV-2 Antibody Tests

No more Mr. Nice Guy. For the first time, the FDA has exercised its enforcement powers to crack down on makers of unproven serologic SARS-CoV-2 antibody tests.

A 180⁰ Pivot

When the public health emergency first began, the FDA allowed producers to introduce antibody tests immediately upon self-validation without Emergency Use Authorization (EUA) via its newly created “Policy D” pathway. Predictably, the US market was soon awash with unproven tests deceptively touted as having FDA approval. The agency sounded the alarm and called on test makers to submit their products to federal labs for independent evaluation. Few did.

The turning point came in early May when, in response to a scathing Congressional investigational report, the FDA put its foot down, ending Policy D and making independent evaluation mandatory for all SARS-CoV-2 antibody tests, including those with EUA. Less than two weeks later, nearly 30 Policy D tests were either delisted or voluntarily withdrawn by their manufacturers.

On June 16, the agency revoked the EUA of one of the first serologic SARS-CoV-2 antibody tests to receive authorization, Chembio Diagnostic’s DPP COVID-19 IgM/IgG test, citing concerns about its sensitivity and specificity. According to the agency, Chembio and independent laboratory evaluation data showed that the test “generates a higher than expected rate of false results and higher than that reflected in the authorized labeling for the device.”

The Warning Letters

Even so, while the FDA had threatened, it did not actually initiate any enforcement actions. But that changed on June 17, the agency announced that it had issued three warning letters to companies for improper marketing of SARS-CoV-2 antibody tests:

• Medakit, which is based in Hong Kong;
• com and Yama Group in the United Arab Emirates; and
• Chicago-based Jason Korkus and Sonrisa Family Dental, doing business as mycovidtest19.com.

The FDA claims the companies were selling tests directly to consumers for at-home use without proper regulatory clearance, approval, or authorization. Among the tests that were improperly marketed, one actually has received EUA, namely, the Cellex Test Kit from Cellex which is sold by Sonrisa. However, the EUA for the test covers only labs certified to perform moderate- and high-complexity tests under CLIA.

The agency asked 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 addition to the following clearances announced in late May and June, the FDA expanded the Fulgent Genetics’ SARS-CoV-2 test EUA to include consumer-initiated testing with the COVID-19 Home Collection Kit offered by Fulgent’s consumer-facing Picture Genetics subsidiary:

New FDA Emergency Use Authorizations (EUAs) & Approvals

New CE Marks & Global Certifications

Notable European CE certifications announced during the period:

NEW CE MARKINGS IN EUROPE

Other international clearances announced during the period: