The company has developed the assay as a 4 in 1 test to help fight against the coronavirus in the wake of its growing spread and flu season
ELITechGroup seeks FDA EUA for ELITe MGB assay (Credit: Belova59 from Pixabay.)
ELITechGroup MDx, a molecular diagnostic testing provider, has filed an application with the US Food & Drug Administration (FDA) for Emergency Use Authorization (EUA) of its SARS-CoV-2 Plus ELITe MGB assay.
The new SARS-CoV-2 Plus ELITe MG assay is designed for the in-vitro qualitative detection and differentiation of RNA from the SARS-CoV-2, Influenza A, Influenza B and Respiratory Syncytial Virus (RSV).
ELITechGroup CEO Christoph Gauer said: “This fall, the United States has seen an alarming surge of COVID-19 cases, and now more than ever, it’s critical we focus on making reliable testing accessible for all health systems.
“By submitting our SARS-CoV-2 Plus ELITe MGB Assay to the FDA for EUA approval, we will provide critical tests that can accurately differentiate from the novel coronavirus and anticipated flus for adults and children.”
ELITechGroup’s assay leverages RNase P as endogenous control for test
Being developed and manufactured in Bothell, Wash, the assay leverages RNase P as an endogenous control for enhanced test reliability, said the company.
The assay is designed to use nasopharyngeal or oropharyngeal swabs and nasal specimens collected from individuals suspected of Covid-19 by the healthcare providers.
According to the company, it can be run on different existing lab instruments, including the ELITe InGenius.
ELITechGroup is a privately held group of manufacturers and distributors of in-vitro diagnostic equipment and reagents.
In December 2019, ELITechGroup has announced the launch of its new Macroduct advanced sweat collection system in Canada.
The new Macroduct featured an advanced touch screen user interface with built in step-by-step graphical instructions to further standardise the sweat collection for optimum results.