NEWPORT, Ky., June 15, 2020 /PRNewswire/ -- Ethos Laboratories has entered a strategic partnership with Genscript to offer the first quantitative surrogate Viral Neutralization Test (sVNT) to evaluate COVID-19 protective immunity in the United States. This test, marketed as Tru-Immune™, will measure and quantify the neutralizing capacity of antibodies against the SARS-CoV-2 virus. Unlike other tests currently on the market, Tru-Immune™ detects the presence and magnitude of neutralizing antibodies that prevent infectivity of the COVID-19 virus.
The Tru-Immune™ lab test will identify patients with the most effective antibody response capable of inhibiting virus replication. This information has notpreviously been available and will pave the way for blood centers across the US to recruit patients who have recovered from COVID-19 and exhibit the greatest potential to inhibit the virus.
The commercialization of the new serological test, marketed by Ethos Labs in the US, will assist government officials and medical authorities to determine population health immunity levels for re-entry into the workforce and establish a "new normal" for American society. In a recent article published by Johns Hopkins University, authors state "neutralization assays are the gold standard for determining if a patient has effective antibodies and protective immunity against SARS-CoV-2. The ability of antibodies to prevent viral replication and clear infection is determined through neutralization assays." 1
According to Joshua Gunn, CSO of Ethos Research and Development, "Tru-Immune is the first test to evaluate protective immunity to the SARS-CoV-2 virus that does not require the use of live virus, cell culture or even pseudovirus. These significant technical innovations allow us to process samples in less than 3 hours whereas traditional viral neutralization tests can take 3-5 days to produce results. Serological assays capable of detecting anti-SARS-CoV-2 antibodies have flooded the market but are not capable of measuring the viral neutralizing capacity of these antibodies."
Tests that are "prefabricated" to detect certain antibodies such as IgG, IgM and IgA, can limit sensitivity, while the Tru-Immune™ test detects all antibody neutralizing capacity and provides quantitative data on how effective your antibodies are at preventing the virus from interacting with its cellular target. If test results indicate the presence of neutralizing antibodies, then you have been exposed and your immune system is capable of inhibiting the virus if exposed again. Longitudinal studies and serial testing will be required to better understand how long the protective antibody response lasts in recovered patients and this information will be key for developing effective vaccine strategies.
"We are excited to offer the first quantitative surrogate viral neutralization test to evaluate Immunity to COVID 19," said Todd Bladel, COO of Ethos Laboratories. "This test was validated using PCR confirmed positive control samples and exhibited sensitivity and specificity of 100%. Tru-Immune™ will provide a level of actionable data that has not been previously available. We feel strongly that this novel test will play a central role in the penultimate chapter of COVID 19 by providing quantitative information about protective immunity, aiding vaccine development, and guiding patient selection for convalescent plasma therapies to treat the critically ill."
About Ethos Laboratories is a clinical diagnostic laboratory located in Newport, Kentucky, dedicated to improving the lives of patients suffering with pain, providing personalized diagnostic services through cutting-edge testing and continuous innovation. Turn-around is among the fastest in the industry, presenting novel levels of transparency, honesty, excellence, and integrity in the laboratory industry. The company focuses on providing excellent quality, service, and support for every customer, and the highest standards for accuracy and efficiency. The laboratory has created innovative tools, resources, and processes that have improved provider insight into sources of pain, increased understanding of medication compliance and management, and fuels the pursuit of continuous improvement including launching a telehealth integration platform.
GenScript is a biotechnology group founded in New Jersey in 2002. The company is listed on the Hong Kong Stock Exchange.