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 Less than two weeks later, nearly 30 Policy D tests were either delisted or voluntarily withdrawn by their manufacturers.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 […]
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 Less than two weeks later, nearly 30 Policy D tests were either delisted or voluntarily withdrawn by their manufacturers.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
| 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 |
| 3B Blackbio | EUA for Biotech India COVID-19 test |
| Bioperfectus Technologies | EUA for COVID-19 Coronavirus Real Time PCR Kit to detect SARS-CoV-2 ORF1ab and N genes |
| Omnipathology Solutions | EUA for Omni COVID-19 ASSAY by RT-PCR |
| Biohit Healthcare | EUA for SARS-CoV-2 IgM/IgG Antibody Test Kit |
| ADS Biotec | EUA for SARS-CoV-2 Antibody Detection Kit |
| Ohio State University | EUA for OSUWMC COVID-19 RT-PCR test |
| Thermo Fisher Scientific | Breakthrough Device Designation for Oncomine Precision Assay to identify low-grade glioma patients with isocitrate dehydrogenase 1 and 2 mutations eligible for treatment with vorasidenib |
New CE Marks & Global Certifications
Notable European CE certifications announced during the period:
NEW CE MARKINGS IN EUROPE
| Manufacturer(s) | Product(s) |
| R-Biopharm | Rida Gene SARS-CoV-2 test |
| Beckman Coulter | Access SARS-CoV-2 IgG antibody test |
| DiaSorin Molecular | Simplexa Congenital CMV Direct kit for detection of cytomegalovirus (CMV) DNA |
| NeuMoDx Molecular | PCR-based NeuMoDx HIV-1 assay |
| Yourgene Health | Iona Nx NIPT Workflow to run on Illumina’s NextSeq 550Dx NGS platform |
| PerkinElmer | Delfia Xpress sFlt-1 kit for predicting preeclampsia |
| Promega | OncoMate MSI Dx Analysis System |
| QuantuMDx | Opti SARS-CoV-2 RT-PCR kit |
| Opti Medical Systems | DeepChek sequencing-based assays for HIV genotyping and drug resistance testing |
| Eurofins Technologies | Ingezim COVID 19 DR total antibody assay for indirect diagnosis of past exposure to SARS-CoV-2 |
| MeMed | MeMed BV diagnostic test and MeMed Key point-of-care platform |
| Mobidiag | Novodiag COVID-19 and Amplidiag COVID-19 PCR tests |
Other international clearances announced during the period:
| Manufacturer(s) | Country(ies) | Product(s) |
| Sysmex | Japan | Ministry of Health, Labour, and Welfare approval for use of saliva with BGI Genomics’ 2019-nCoV Fluorescence Detection Real-Time RT-PCR Kit |
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