ELITechGroup MDx LLC Announces FDA Emergency Use Authorization Submission for SARS-CoV-2 Plus ELITe MGB® Assay


BOTHELL, Wash., Nov. 17, 2020 /PRNewswire/ -- Today, ELITechGroup MDx LLC, a leading global provider of molecular diagnostic testing products, announced it submitted the SARS-CoV-2 Plus ELITe MGB® Assay to the U.S. Food & Drug Association's (FDA's) 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 detection 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, Wash., and it uses RNase P as an endogenous control for increased test reliability. It is designed for use on a variety of existing lab instruments, including the ELITe InGenius®.

"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," said Christoph Gauer, ELITechGroup CEO. "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." 

To learn more or order the SARS-CoV-2 Plus ELITe MGB® Assay 100-test kit, or to see if it can be used on your current lab instruments, call (800) 453-2725 or email at MDxSales@elitechgroup.com. For more information about ELITechGroup MDx in the United States, please visit ELITechGroup.com/North-America/.

About ELITechGroup MDx LLC:
ELITechGroup is a privately held group of worldwide manufacturers and distributors of in vitro diagnostic equipment and reagents. By bringing together IVD specialty companies 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.



Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/elitechgroup-mdx-llc-announces-fda-emergency-use-authorization-submission-for-sars-cov-2-plus-elite-mgb-assay-301174075.html



Back to news