ELITechGroup MDx LLC to Introduce the SARS-CoV-2 Plus in Early October

MedTech Outlook | Monday, October 19, 2020

ELITechGroup MDx LLC is launching the SARS-CoV-2 Plus that can be utilized for Research Use Only (RUO) in the United States.

FREMONT, CA: ELITechGroup MDx LLC, a prominent worldwide provider of molecular diagnostic testing products, has announced that it is launching the SARS-CoV-2 Plus that can be utilized for Research Use Only (RUO) in the United States. It will be introduced in early October. The SARS-CoV-2 Plus RUO utilizes nasopharyngeal and nasal swab specimens to test five infectious diseases, including SARS-CoV-2 (ORF1ab & ORF8), influenza A, influenza B, and respiratory syncytial virus (RSV).

The SARS-CoV-2 Plus RUO reagents have been developed and manufactured in Bothell, Wash. The product's design will help it use several existing lab instruments, which even consist of the ELITe InGenius. The SARS-CoV-2 Plus RUO makes use of RNase P as an endogenous control so that it can increase test reliability and is available under Research Use Only for laboratory facilities for validating the reagents.

"In anticipation of a severe flu season in tandem with the ongoing novel coronavirus, it's imperative that hospitals and labs are equipped with highly-effective tests," said Christoph Gauer, ELITechGroup CEO. "We remain committed to helping healthcare workers on the front lines and will submit our SARS-CoV-2 Plus Assay to the FDA for Emergency Use Authorization (EUA) at the end of October."

ELITechGroup is a privately held group of global manufacturers and distributors in vitro diagnostic equipment and reagents. By collaborating with the IVD specialty organizations that offer advanced products and solutions, ELITechGroup has become a primary contributor in evolving clinical diagnostics to laboratories in the proximity market that operates closer to patients.