First Commercial Unit Placed at Dartmouth-Hitchcock MC LexaGene Places a Pre-Commercial Instrument for COVID-19 Testing in a Major Hospital Laboratory
BEVERLY, Mass. – May 28, 2020 – LexaGene Holdings, Inc., (TSX-V: LXG; OTCQB: LXXGF) (the “Company”) a biotechnology company that develops genetic analyzers for rapid pathogen detection and other molecular markers, is pleased to announce the placing of a pre-commercial instrument that tests for COVID-19 and other respiratory pathogens at the Dartmouth-Hitchcock Medical Center (DHMC) in their Laboratory for Clinical Genomics and Advanced Technology (CGAT) in Hanover, New Hampshire.
Dr. Gregory J. Tsongalis, PhD, HCLD, CC, Professor and Vice Chair for Research Director at CGAT comments, “Our standard test for SARS-CoV-2, the pathogen that causes COVID-19, takes about 7.5 hours. Given the highly contagious nature of this virus, this is a long time to wait. We want the ability to get results much faster and to be able to screen for more pathogens at once since respiratory symptoms can be caused by numerous other viruses.”
Dr. Jack Regan, LexaGene’s Founder and CEO, states, “We are excited to be able to contribute to the fight against COVID-19 and illustrate our applications in the human clinical space. Unlike many of the near-patient testing solutions used today that only look for COVID-19 and have a significant false negative rate, the instrument we have placed at Dartmouth-Hitchcock screens for many pathogens at once, namely COVID-19, influenza, RSV, adenovirus, metapneumovirus, and seasonal coronavirus, and it performs gold-standard chemistry for exceptional data quality. Our breadth of detection allows users of our technology to generate informative data for the vast majority of people with respiratory symptoms. This is particularly important as healthcare providers are increasingly questioning negative results from COVID-19 only tests, wondering if the test result is a false negative or the person is sick from another pathogen.”
The Company is also pleased to report that we have submitted our plan to the FDA for Emergency Use Authorization (EUA) for COVID-19 testing and anticipates completing the described studies in the near future. Until these studies are completed and the FDA grants LexaGene’s instrument EUA for COVID-19 testing, all work using LexaGene instruments is classified as Research Use Only and cannot be used for human clinical diagnostics.