LexaGene Provides Corporate Update
Responds to demand for better diagnostics of COVID-19
BEVERLY, Mass. – March 11, 2020 – LexaGene Holdings, Inc., (OTCQB: LXXGF; TSX-V: LXG) (the “Company”), a biotechnology company that develops genetic analyzers for rapid pathogen detection and other molecular markers, provides the following corporate update on the development of its commercial technology and information on how the Company has responded to the demand for its technology in view of the COVID-19 outbreak.
In response to the COVID-19 outbreak, the World Health Organization has declared a ‘Public Health Emergency of International Concern’ and the FDA has encouraged CLIA labs and IVD manufacturers to submit applications for Emergency Use Authorization (EUA) to help address the lack of quality diagnostics to fight this disease. The FDA’s track record of granting EUA during declared emergencies, such as the Ebola and Zika outbreaks, provides management confidence that the Company’s decision to pursue EUA is in the best interest of its shareholders, its future customers and the patients they serve. Due to the overwhelming interest in LexaGene’s rapid, on-site analyzer for the detection of novel infectious diseases like COVID-19, LexaGene is taking every measure to accelerate its FDA EUA submission.
LexaGene CEO and Founder, Dr. Jack Regan explains, “The rapid spread of the novel disease COVID-19, with infections reported in more than 90 countries and 37 U.S. states, highlights the failure of existing diagnostics to contain a novel pathogen successfully. To contribute to the solution for this outbreak and make us better prepared for the next outbreak, LexaGene is now aggressively pursuing the clinical diagnostics market. We also have the personnel in place to remain on track to penetrate veterinary diagnostics, food safety and other markets that require open-access testing.”
Since the coronavirus outbreak, LexaGene has not only performed in-house testing on its LX Analyzer using the CDC’s coronavirus test, but the Company is also developing robust tests of its own for SARS-CoV-2, the pathogen that causes COVID-19, as well as tests for influenza A & B, human metapneumovirus, RSV, and human adenovirus, as a start for a syndromic respiratory panel. LexaGene is talking to several groups about placing one of its beta instruments in the field for research coronavirus testing. The Company plans to submit its own COVID-19 test to the FDA for EUA to be run on the LX Analyzer.
Over the last several months, LexaGene has made significant enhancements to the LX Analyzer, resulting in advanced performance while reducing manufacturing costs for improved margins of the commercial unit. The Company has begun manufacturing some of the more complicated components of the instrument, such as its optical module, and made several improvements to the analyzer’s design, including:
– Design work for improved manufacturing and serviceability
– 30% reduction in size for an upgraded optical module
– 40% reduction in manufacturing costs for improved unit pricing
– 15-fold improvement in sensitivity due to a new sample prep cartridge (from initial data)
– A new fluidic configuration that reduces number of pumps and valves by half
– Progress towards developing software to improve system usability
Furthermore, the Company has recently contracted an internationally renowned industrial design firm, Ximedica, to accelerate its commercialization efforts. In addition, the Company is in the final stages of hiring key positions in sales, product marketing, quality, regulatory affairs, engineering, and application support. The Company expects to announce some of these hires in the near future.
LexaGene President and Co-founder Daryl Rebeck concludes, “LexaGene’s progress has been tremendous. We’re doing each step of development properly and we are on track to deliver a next-generation pathogen detection system in Q3 of this year.”
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.
The TSX Venture Exchange Inc. has in no way passed upon the merits of the proposed transaction and has neither approved nor disapproved the contents of this press release. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
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.