HomeBIOTECHNOLOGYSARS-CoV-2 Plus ELITe MGB Assay EAU Submitted

SARS-CoV-2 Plus ELITe MGB Assay EAU Submitted

SARS-CoV-2 Plus ELITe MGB® Assay 4 in 1 Test Will Help Fight Against the Novel Coronavirus Amidst Growing Spread and Flu Season

November 17, 2020

SARS-CoV-2 Plus ELITe MGB® Assay has been submitted to the U.S. Food & Drug Association’s for Emergency Use Authorization , following the Molecular Diagnostic Template for Commercial Manufacturers.

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.”

Additional information can be found here.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected

spot_img

Don't Miss

Mark Foster Joins Xenocor BOD

Foster is a versatile and visionary C-Suite executive who brings 20 years of general management and leadership experience from both venture-backed growth-stage organizations and world-class medical device companies

Hinge Health Acquires the Most Advanced Computer Vision Technology for Tracking Human Motion

CEO Daniel Perez explained, “We won’t stop investing in technology to deliver the most patient-centered digital clinic that improves member experience and outcomes while reducing costs. wrnch allows us to take a giant leap forward in all respects.”

Dale W Wood Congratulates the Huma Team on Raising $130 Million

Major health and technology companies across the world have committed upwards of $130 million to Huma Therapeutics, the health-tech company backed by Dale Ventures.

Rhaeos Awarded $4 Million NIH SBIR Grant

Under the NIH SBIR grant, Rhaeos will leverage their existing wireless sensor hardware to provide additional quantitative flow data to the clinician, giving insight into this currently inaccessible and highly relevant shunt performance metric.

Gynesonics Announces FDA Clearance of Next Generation Sonata System

“This clearance brings significant system improvements that expand the location of fibroids that can be treated while allowing the physician to control all aspects of the treatment from within the sterile field,” said Jiayu Chen, Ph.D. Vice President, Engineering and Advanced Technologies at Gynesonics.

Blackrock Neurotech Invests In Groundbreaking Auditory Nerve Implant With University Of Minnesota And MED-EL

The new investment will enable the development and translation of a new ANI through preclinical studies and later, a pilot clinical trial, where the ANI is then implanted in up to three deaf patients.

Jonathan Chapman: New President/CEO of Trividia Health

Chapman said, “I’m honored to join the Trividia team as President and CEO. This organization has a long history of leadership within the healthcare industry as a provider of accurate, accessible, and affordable point-of-care solutions for the management of diabetes.”

SOLOPASS® System (Bedside Neuro-Navigation Device) Receives FDA 510(k) Clearance

inTRAvent’s SOLOPASS® system brings simple, portable, bedside neuro-navigation into the intensive care unit.

By using this website you agree to accept Medical Device News Magazine Privacy Policy