FDA Watch

First Enforcement Action for Improper Marketing of SARS-CoV-2 Antibody Tests

After initially allowing producers of serologic SARS-CoV-2 antibodies tests free access to the market, the US Food and Drug Administration (FDA) is now cracking down on unproven and inaccurate tests.

No More Mr. Nice Guy

The turning point came in early May when, in response to heavy criticism and a scathing Congressional investigational report, the FDA withdrew its controversial “Policy D” allowing the marketing of SARS-CoV-2 antibody tests upon internal self-validation without need for Emergency Use Authorization (EUA), demanding that producers submit their tests to a federal laboratory for independent evaluation. Less than two weeks later, nearly 30 Policy D tests were delisted and/or voluntarily withdrawn by their manufacturers.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

But until now, the agency had not initiated any enforcement action—even though it recognized almost immediately that test makers were taking advantage of Policy D and making unsubstantiated claims about their products. But on June 17, the FDA announced that it has, in fact, issued warning letters—three of them in the past week—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 laboratories certified to perform moderate- and high-complexity tests under CLIA.

“To date, FDA has not approved, cleared, or authorized any COVID-19 serology test for at-home testing,” noted the agency in the warning letters it sent to the three companies. While some COVID-19 sample collection kits have been authorized for at-home use, the agency has not granted EUA of any test, antibody or molecular, for home use from start to finish that includes the actual running of the test.

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.


Here are some of the key new FDA EUAs and clearances announced in late May through June 18:

New FDA Emergency Use Authorizations (EUAs) & Approvals

Manufacturer(s) Product
Illumina EUA for Illumina COVIDSeq Test, first NGS test to get EUA for detecting SARS-CoV-2
Roche Clearance for Cobas EZH2 Mutation Test as companion diagnostic for Epizyme’s tazemetostat (Tazverik) for relapsed follicular lymphoma patients with EZH2 mutation
Roche EUA for Elecsys IL-6 test to identify severe inflammatory response in COVID-19 patients
Foundation Medicine Clearance for FoundationOne CDx as a companion test for Merck’s Keytruda (pembrolizumab)
Emory University EUA for SARS-CoV-2 RBD IgG ELISA-based serologic test
Kaiser Permanente EUA for KPMAS COVID-19 Test + home collection kit
Applied BioCode EUA for SARS-CoV-2 Assay
Quidel Amended EUA to run Sofia SARS Antigen FIA on Sofia Fluorescent Immunoassay Analyzer
RTA Laboratories EUA for Diagnovital SARS-CoV-2 Real-Time PCR Kit
Cormeum Laboratory Services EUA for SARS-CoV-2 assay detecting N, S + Ofr1ab regions in virus’ genome
Cue Health EUA for Cue COVID-19 Test
Tide Laboratories EUA for DTPM COVID-19 RT-PCR test
TBG Biotechnology EUA for ExProbe SARS-CoV-2 Testing Kit
ChromaCode EUA for announced Wednesday HDPCR SARS-CoV-2 Real-Time PCR assay
Siemens Healthineers EUA for Dimension Vista SARS-CoV-2 total antibody assay + Dimension EXL SARS-CoV-2 total antibody assay
Euroimmun EUA for EuroRealTime SARS-CoV-2 molecular assay
Phosphorus Diagnostics + Genetron Health EUA for COVID-19 RT-qPCR Test detecting SARS-CoV-2 RNA in saliva specimens collected by providers or patients at home
Quest EUA for Self-collection Kit for COVID-19
SpectronRx EUA for Hymon SARS-CoV-2 Test Kit
Exact Sciences EUA for SARS-CoV-2 (N gene detection) Test
Express Gene Molecular Diagnostics Laboratory EUA for 2019-nCoV RT-PCR Diagnostic Panel
Avera Institute for Human Genetics EUA for SARS-CoV-2 assay run on the Applied Biosystems Quant Studio 7 Flex
P23 Labs EUA for TaqPath SARS-CoV-2 test
BioCore EUA for 2019-nCoV Real Time PCR Kit
SolGent EUA for DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit
Seasun Biomaterials EUA for AQ-TOP COVID-19 Rapid Detection Kit
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