Truvian’s Easy Check will create higher standards of performance, speed, and scalability for the rapid detection of IgM/IgG antibodies to SARS-CoV-2
SAN DIEGO, June 17, 2020 — Truvian Sciences (“Truvian”), a healthcare company at the intersection of diagnostics and consumer technology, today announced Easy Check COVID-19 IgM/IgG, a rapid, highly accurate and scalable COVID-19 antibody test. Easy Check has been validated by leading healthcare professionals and scientific experts from across the U.S. and is currently being evaluated by the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization. Easy Check will be available to order upon FDA EUA approval.
Truvian’s Easy Check antibody test requires a drop of whole blood, serum or plasma and delivers results at 10 minutes with a sensitivity and specificity that rivals lab-based COVID-19 antibody tests, making it one of the most accurate tests on the market.
“Rapid, affordable and highly accurate COVID-19 antibody testing that can be delivered at scale will play a critical role in the fight against this global pandemic,” said Jeff Hawkins, President and Chief Executive Officer of Truvian. “Unfortunately, many antibody tests have been rushed to market and have missed the mark in terms of performance and manufacturing capacity. Truvian is ensuring our serology test is validated by experts on the front lines of this global health crisis. Not only was Easy Check developed to meet the requirements of the FDA for EUA, we also conducted studies alongside the medical community to ensure the product is rigorously validated by independent experts.”
“Serology testing is a valuable tool for understanding SARS-CoV-2 exposure and necessary from a public health response perspective to estimate the number of people who have been infected in various regions and settings,” said Dr. Jerry Yeo, Professor of Pathology and Medical Director of Clinical Chemistry at the University of Chicago. “Our studies with Truvian’s Easy Check COVID-19 IgM/IgG were designed to evaluate the performance, including clinical sensitivity, clinical specificity, and cross-reactivity of the test. Our results indicate Easy Check not only meets — but surpasses — performance criteria required by the FDA. In addition, we have found Easy Check demonstrates high concordance to laboratory-based serology tests which gives it great potential for use at the point of care setting.”
“A number of serology tests have come on the market with inadequate performance, limiting their usefulness and utility. We evaluated several lateral flow antibody tests internally and have been impressed with the sensitivity, specificity, and usability of Truvian’s Easy Check COVID-19 IgM/IgG test,” said Dr. Davey Smith, head of the division of Infectious Diseases and Global Public Health at UC San Diego. “We applaud Truvian’s focus and efforts to validate and deliver such a scientifically sound and highly accurate lateral flow antibody test and will continue to work with Truvian on various research studies, looking at seroconversion and duration of immune response in patients previously diagnosed with SARS-CoV-2.”
Easy Check will endeavor to deliver testing results that will aid the public health response and planning efforts around COVID-19. This includes sero-epidemiologic surveillance to better estimate the number of people previously infected to inform public health measures and infection fatality rate. It will also provide an objective measure to define chains of transmission or connections to case clusters and better help with the management of exposed individuals, which is critical to help people and companies evaluate risk factors when making crucial decisions. Additionally, Easy Check test results may assist with monitoring essential health care workers through rapid testing availability and aid in vaccine development.
For more information about Truvian and the Easy Check COVID-19 antibody test, please visit www.truvianhealth.com.
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.
Heath Meyer and Valerie Enes