Truvian Receives FDA Emergency Use Authorization for COVID-19 IgM/IgG Test

Truvian Sciences announced the U.S. Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for the company's Easy Check COVID-19 IgM/IgGTM antibody test. Truvian's Easy Check test is being produced at mass scale at a US based manufacturing facility and will be available to healthcare practitioners immediately.

The test, which has been rigorously tested and validated by leading healthcare professionals and scientific experts at University of California San Diego (UCSD) and the University of Chicago, exceeds the current EUA requirements for current COVID-19 antibody tests by delivering a sensitivity rate of 98.44 percent and a specificity of 98.9 percent. Additionally, the cross-reactivity evaluation determined no cross-reactivity (0 percent) with HIV, Influenza A and B and several coronavirus strains.

Further validation by the Frederick National Laboratory for Cancer Research (FNLCR) sponsored by the National Cancer Institute (NCI) resulted in combined sensitivity of 100 percent and combined specificity of 97.5 percent.

"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," said Jeff Hawkins, President and Chief Executive Officer, Truvian Sciences. "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."

"The FDA's EUA validates the extensive testing our team at the University of Chicago has conducted on Truvian's Easy Check solution," said Dr. Jerry Yeo, Professor of Pathology at the University of Chicago. "Given the recent removal of numerous SARS-CoV-2 Antibody tests by the FDA due to significant clinical performance issues, it is imperative that any new antibody test is fully validated by several external CLIA-certified laboratories before being implemented for clinical use. Having done an extensive evaluation on Truvian's device, I firmly believe that Easy Check delivers the accuracy and clinical performance as stipulated by the FDA, and sets the tone for what the medical community needs in terms of a highly reliable antibody test. Truvian's antibody test will aid in providing key data that will allow us to better estimate the number of people previously infected to inform public health measures, and may assist in the broader availability of treatments such as convalescent plasma, which requires blood donations from individuals previously exposed COVID-19."