ELITechGroup MDx has 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®.
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"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."