FDA Emergency Authorization: IgG/IgM Rapid Coronavirus Diagnostic

Premier Biotech released a statement revealing that the US Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) to its SARS-CoV-2 IgG and IgM rapid diagnostic.

The test uses whole blood, plasma, or serum. The testing kit is intended to produce reliable results within 10 minutes.

"The FDA's decision to grant Biotest's product EUA is great news for communities across the U.S. that continue to struggle to access adequate COVID-19 testing, which healthcare experts agree is essential to successful recovery from the COVID-19 crisis," said Premier Biotech CEO Todd Bailey in the announcement release.

False negatives and variable reliability plagued earlier tests across the diagnostics industry, but Premier claimed that the test met rigorous testing standards. Premier Biotech attracted the skepticism of a U.S. House subcommittee over concerns its tests are not as accurate as presented.

Premier has defended its previous tests, and intends to release more information on accuracy as it emerges.

"As the grant of EUA confirms, the National Cancer Institute has verified this product exceeds the 95% specificity and 90% sensitivity standards set by the FDA. Undoubtedly, this product is in clear alignment with Premier Biotech's rigorous compliance standards and commitment to distributing high-quality testing solutions. We will continue to follow the regulatory guidelines closely as we distribute the product for emergency use to authorized laboratories nationwide.”

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