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FDA Declines to Review EUA for Chembio Diagnostics SARS-CoV-2 Antibody Test

NEW YORK – In a document filed with the US Securities and Exchange Commission Thursday, Chembio Diagnostics reported its Emergency Use Authorization submission for a SARS-CoV-2 antibody test was deprioritized by the US Food and Drug Administration.

As a result, the agency will not review Chembio's EUA submission for the test.

The company's DPP SARS-CoV-2 IgM/IgG test was submitted to the agency in September, but FDA responded Thursday declining to review the request because it would have "relatively limited impact on testing accessibility or testing capacity," Chembio wrote in the Form 8-K. FDA has been prioritizing EUA requests based on public health need for the product and its availability, among other factors. 

"We intend to work with the FDA to seek to establish priority for our IgM/IgG EUA, based on our belief that the DPP SARS COV-2 IgM/IgG with DPP Micro Reader would increase testing accessibility," the company said it is SEC document. 

Chembio's test uses its dual-path-platform (DPP) immunochromatographic technology, which it says has advantages over lateral flow technology, namely the ability to run a variety of sample types and detection of multiple analytes on a single cassette.

In June, the agency revoked its EUA of Chembio's earlier SARS-CoV-2 serology test due to concerns about its sensitivity and specificity after the National Cancer Institute performed a validation of the test. The test also generated a high rate of false results and was inconsistent , the FDA said. 

On Wednesday, Chembio received $12.7 million from the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority to develop a rapid, multiplex DPP Respiratory Antigen Panel point-of-care system for use throughout the flu season.