LexaGene’s Analyzer is Designed to Detect Pathogens such as the Novel Coronavirus to Help Avert a Pandemic
BEVERLY, Mass. – January 27, 2020 – LexaGene Holdings, Inc., (OTCQB: LXXGF; TSX-V: LXG) (“LexaGene” or the “Company”), a biotechnology company that develops genetic analyzers for the rapid detection of pathogens and other molecular markers, has received many inquiries regarding the ability of LexaGene’s technology for detecting coronavirus.
“LexaGene’s technology is ideally suited to identify novel pathogens such as coronavirus. Our genetic analyzer can quickly detect new pathogens in just one hour, on-site. Currently, the traditional process requires that samples from sick individuals must be transported to laboratories for manual processing. This is extremely inefficient and introduces a significant time-delay that can have severe consequences for disease spread. Today’s coronavirus outbreak highlights why LexaGene’s technology is needed so desperately,” said Dr. Jack Regan, LexaGene’s CEO and Founder.
This new pathogen first emerged in mid-December when several workers in the Huanan Seafood Market of Wuhan, China displayed symptoms of severe pneumonia from an unknown pathogen. On January 9th, China CDC reported that the infections were due to a novel coronavirus, currently referred to as 2019-nCoV. In an attempt to control disease spread, the Chinese government has quarantined entire cities, and international airports are now screening travelers from affected areas. Despite these efforts, the World Health Organization reported that by January 26th, over 2,000 cases had been confirmed and 56 deaths were reported.1 Human-to-human transmission has been confirmed and the disease has quickly spread to ten other countries, including the United States, France, Canada, and Australia. The risk of a pandemic is now very real.
Dr. Regan continues, “Developing a new diagnostic test to detect this coronavirus is important and has already been done by numerous groups.2 The challenge is bringing these manually performed tests out of the specialized reference laboratories that can take days to return results and instead to the points-of-need, which are the clinics, hospitals, and airports where answers are needed in one hour or less. Currently, no technology exists that allows for these locations to readily start screening for a new threat within days of an outbreak being identified. LexaGene is addressing this urgent problem and has developed the first ever, easy-to-use, open-access diagnostic analyzer that is designed to help control the spread of deadly outbreaks such as this 2019 coronavirus.”
LexaGene’s microfluidic technology is designed for on-site use and screens for both common pathogens and new bio-threats. This is possible due to its open-access feature that permits non-technical operators to quickly add new tests to detect novel pathogens.
LexaGene is now finalizing the design of its commercial instrument, which it anticipates starting to manufacture in a few months, with the expectation of achieving first commercial sales in Q3 of this year. For implementation in hospitals, clinics, airports, and other locations interested in processing human samples for clinical purposes, the Company will need either Emergency Use Authorization (EUA) or 510(k) clearance from the Food and Drug Administration (FDA).
About LexaGene Holdings Inc.
LexaGene is a biotechnology company that develops genetic analyzers for pathogen detection and other molecular markers for on-site rapid testing in veterinary diagnostics, food safety and for use in open-access markets such as clinical research, agricultural testing and biodefense. End-users simply need to collect a sample, load it onto the instrument with a sample preparation cartridge, enter sample ID and press ‘go’. The LX Analyzer delivers excellent sensitivity, specificity, and breadth of detection and can return results in about 1 hour. The unique open-access feature is designed for custom testing so that end-users can load their own real-time PCR assays onto the instrument to target any genetic target of interest.
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This news release contains forward-looking information, which involves known and unknown risks, uncertainties and other factors that may cause actual events to differ materially from current expectation. Important factors — including the availability of funds, the results of financing efforts, the success of technology development efforts, the cost to procure critical parts, performance of the instrument, market acceptance of the technology, regulatory acceptance, and licensing issues — that could cause actual results to differ materially from the Company’s expectations as disclosed in the Company’s documents filed from time to time on SEDAR (see www.sedar.com). Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The company disclaims any intention or obligation, except to the extent required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.