Seattle-based ELITechGroup MDx announces the submission of the SARS-CoV-2 Plus ELITe MGB Assay to the FDA for Emergency Use Authorization (EUA).
FREMONT, CA: ELITechGroup MDx, a pioneering provider of molecular diagnostic testing products, announces the submission of SARS-CoV-2 Plus ELITe MGB Assay to the U.S. Food & Drug Associations (FDAs) for Emergency Use Authorization (EUA), following the Molecular Diagnostic Template for Commercial Manufacturers. The SARS-CoV-2 Plus ELITe MGB Assay is for the in vitro qualitative identification and differentiation of RNA from the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Influenza A (Flu A), Influenza B (Flu B), and Respiratory Syncytial Virus (RSV) in nasopharyngeal/ oropharyngeal swabs and nasal specimens from patients suspected of COVID-19 by a healthcare provider.
The SARS-CoV-2 Plus ELITe MGB Assay is developed and manufactured in Bothell, and it uses RNase P as an endogenous control for increased test reliability. It is developed for use on a variety of existing lab instruments, including the ELITe InGenius. This fall, the U.S. has seen a surge of COVID-19 cases, and now more than ever, so it is vital to focus on making reliable testing accessible for health systems. By submitting SARS-CoV-2 Plus ELITe MGB Assay to the FDA for EUA approval, the company will provide critical tests that can accurately differentiate from the novel coronavirus and anticipated cases of flu for adults and children.
ELITechGroup is a privately held group of manufacturers and distributors of in vitro diagnostic equipment and reagents. By bringing together IVD specialty firms that offer innovative products and solutions, ELITechGroup has become a major contributor in advancing clinical diagnostics to laboratories in the proximity market, those operating closer to the patient.