ELITechGroup’s Rapid Detection Test Kits Secure FDA Emergency Use Authorization

ELITechGroup MDx LLC (Puteaux, France), a global provider of diagnostic testing products, and its Korean partner, OSANG Healthcare (South Korea), have secured Emergency Use Authorization (EUA) from the FDA for its SARS-CoV-2 virus test for use in the US.

The GeneFinder COVID-19 Plus RealAmp Kit provides a fast and easy-to-use diagnostic solution to rapidly identify clusters of infection and has been validated using the ABI 7500 thermocycler and Bio-Rad CFX96 cycler – both popular Polymerase Chain Reaction (PCR) instruments found in diagnostics laboratories throughout the US. Delivering qualitative results within hours, the highly sensitive testing kit requires a single tube rather than multiple reactions and uses Aveolar fluid, throat swab or sputum samples in a PCR instrument to detect the virus.

To date, ELITechGroup has delivered more than 700,000 COVID-19 CE-IVD tests worldwide that have proven effective in accurately detecting the infection. ELITechGroup MDx is the exclusive distributor of the test kits to certain markets across the US.

"The dramatic explosion of the novel coronavirus is affecting lives in every state," said ELITechGroup CEO, Christoph Gauer. "Hospitals and labs need access to reliable COVID-19 test kits, and we are here to support the medical professionals on the front lines working to prevent the spread of COVID-19."

"We are determined to fight COVID-19 and the alarming infection rates now being seen in the U.S.," said OSANG Healthcare Chairman Dong-Hyun Lee. "We are pleased to partner with ELITechGroup MDx to bring much needed testing kits to U.S. shores."