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FDA issues EUA for Truvian COVID-19 test

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Truvian Sciences announced that it received FDA emergency use authorization (EUA) for its Easy Check COVID-19 IgM/IgG antibody test.

San Diego-based Truvian’s test is now being produced at a mass scale at a U.S.-based manufacturing facility and will be made available to healthcare practitioners immediately, according to a news release.

The test has undergone validation at the University of California San Diego and University of Chicago, recording 98.44% sensitivity and 98.9% specificity and no cross-reactivity with HIV, influenza A and B and several coronavirus strains. Further validation at the Frederick National Laboratory for Cancer Research found a sensitivity of 100% and specificity of 97.5%.

“Truvian’s Easy Check performed exceptionally well, with a robust sample set, in both our own studies, as well as the studies conducted by independent laboratories,” Truvian Sciences President & CEO Jeff Hawkins said in the release. “With its consistent reproducibility, we are confident our testing solution, backed by the FDA’s EUA, will set a higher bar for COVID-19 antibody testing.”

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