Company submits POC test for FDA Emergency Use Authorization, completes the Section IV.D notification process.
SAN DIEGO, Oct. 26, 2020 – Truvian Sciences (“Truvian”), a healthcare company at the intersection of diagnostics and consumer technology, today announced its submission of the Easy Check COVID-19 IgM/IgG™ Point-of-Care (POC) Antibody Test to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA). Additionally, the company released clinical study data for the Easy Check POC Antibody Test with a fingerstick sample, and reported the test’s completion of the Section IV.D notification process under FDA’s Policy for Coronavirus Disease-2019 tests during the Public Health Emergency (Revised).
In a new clinical study, a total of 140 fingerstick whole blood samples were collected at three different POC sites in United States. The Easy Check COVID-19 IgM/IgG POC Antibody Test met FDA acceptance criteria required for a POC test. The sensitivity and specificity rates rival other lateral flow COVID-19 antibody tests and make the Easy Check COVID-19 IgM/IgG POC Antibody Test one of the best performing COVID-19 antibody tests available today.
“Our goal is to give individuals unprecedented access to their healthcare information, and by deploying serology testing at the point-of-care we can make it easier for individuals to better understand if they have previously been exposed to the disease,” said Jeff Hawkins, President and Chief Executive Officer of Truvian. “Our fingerstick test will eliminate the need for a blood draw and for outsourcing testing to centralized labs, reducing the sample-to-answer timeframe from days down to 10 minutes while maintaining a high level of accuracy.”
The pending FDA EUA for the Easy Check COVID-19 IgM/IgG POC Antibody Test will enable healthcare providers to deploy COVID-19 antibody testing using fingerstick whole blood samples at the point-of-care in a CLIA-waived environment. The test will expand Truvian’s portfolio of COVID-19 antibody testing solutions, which includes the Easy Check COVID-19 IgM/IgG™ Antibody Test that received FDA EUA approval in July 2020 for use in medium to high-complexity CLIA laboratories with serum, plasma or venous blood samples.
The Easy Check COVID-19 IgM/IgG POC Antibody Test is an immunochromatographic lateral ﬂow assay intended for the qualitative detection and diﬀerentiation of Immunoglobulin M (IgM) and/or Immunoglobulin G (IgG) antibodies to SARS-CoV-2 with a ﬁngerstick whole blood specimen.
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.