Truvian Sciences Receives FDA Emergency Use Authorization for Easy Check COVID-19 IgM/IgG™ Test
Rigorously and independently tested and validated, Easy Check exceeds current testing requirements for the detection of IgM/IgG antibodies to SARS-CoV-2
Jul 29, 2020, 08:00 ET
SAN DIEGO, July 29, 2020 /PRNewswire/ -- Truvian Sciences ("Truvian"), a healthcare company at the intersection of diagnostics and consumer technology, today announced that 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."
Truvian's Easy Check test is available for order now by emailing [email protected]. For more information about Truvian and the Easy Check COVID-19 antibody test, please visit https://truvianhealth.com/easycheck.
About Truvian Sciences
Truvian is a healthcare company at the intersection of diagnostics and consumer technology. Its automated benchtop system is being developed to produce lab-accurate results for a full-suite of health tests using a small sample of blood. Powered by patented technologies and intelligent integration, Truvian's system delivers a convenient and affordable alternative to off-site labs, providing immediate insights to inform healthcare decisions. Truvian was founded by individuals with deep domain experience in healthcare, diagnostics and consumer technology. Today, the team has expanded to include top scientists, engineers, and healthcare business leaders — each bringing specialized expertise to drive Truvian's mission of making routine health testing convenient, affordable and actionable. For more information, visit www.truvianhealth.com.
SOURCE Truvian Sciences
