BEVERLY, Mass. USA – October 26, 2021 – LexaGene Holdings, Inc., (OTCQB: LXXGF; TSX-V: LXG) (“LexaGene” or the “Company”), a molecular diagnostics company that has commercialized an instrument for automated multiplex PCR testing for veterinary diagnostics, today announced it has finalized the design of the MiQLab™ Pneumonia Panel for companion animals and completed initial multiplex testing.
In June 2021, LexaGene and Ethos Discovery partnered to develop a pneumonia panel to expand the utility of the MiQLab in veterinary diagnostics. Since then, LexaGene has been working closely with Ethos Discovery to design and validate a panel for rapidly determining the cause of pneumonia while simultaneously screening for antimicrobial resistance factors that should be taken into account when treating such infections in companion animals. Respiratory illnesses can cause significant health concerns for the animals and can have significant financial impact on pet care businesses, such as hospitals, kennels, shelters, and dog daycare camps, which often have to shut down in the event of an outbreak.
Chand Khanna, DVM, PhD, DACVIM (Onc), the President of Ethos Discovery, commented, “The opportunity to diagnose and treat pet animals with complex medical problems, such as pneumonia, using a point of care instrument will significantly improve outcomes for veterinary patients. Currently, it takes days to get culture-based test results back from a reference laboratory, which delays the initiation of life-saving treatments for patients. Furthermore, rapidly determining whether any antimicrobial resistance was also detected would improve the efficacy of treatment plans.”
Dr. Jack Regan, CEO and Founder of LexaGene stated, “The MiQLab Pneumonia Panel will be our second product launched for veterinary diagnostics and it will significantly expand the utility of the MiQLab. Our first panel, the MiQLab Bacterial and AMR V2 Test is currently being used for definitive diagnosis of infections such as those involving urinary tract, skin, wound, and ear. Because there are many different pathogens that cause acute respiratory distress, we designed a panel to specifically help veterinarians quickly diagnose respiratory illness in animals for impactful care and treatment decisions.”
He continued, “Ethos has collected some respiratory samples and has agreed to send them to LexaGene so that we can complete an analytical evaluation of the panel. As a next step, Ethos Discovery will conduct a clinical evaluation of the pneumonia panel on their purchased MiQLab.”
The MiQLab Pneumonia Panel includes 13 assays targeting bacteria and 4 assays targeting fungi, plus 19 assays targeting antimicrobial resistance genes. Specifically, the bacterial targets include: Pseudomonas, Enterobacter, Enterococcus, Klebsiella, Bordetella, Staphylococcus, Pasteurella, Escherichia coli, Actinomyces, Streptococcus, Mycoplasma, an assay to detect a subset of Gram positive bacteria, and an assay to target a subset of the Gram negative bacteria (mostly the Enterobacteriales Order); the fungal targets include: Histoplasma, Blastomyces, Coccidioides, and Cryptococcus; and the antimicrobial resistance targets include: tetA, tetB, tetC, tetG, tetD, tetJ, tetK, tetL, tetM, tetO, tetS, tet38, CMY, SHV, TEM, CTX-M-1, CTX-M-9, mecA, and gyrA (fluoriquinolone resistance in Klebsiella and Pseudomonas).
To develop this product, the following has been completed: 1) selection of targets for inclusion in panel, 2) multiple in-silico PCR designs for each target, 3) wet lab single-plex testing of all designs to select the best performing assays, and 4) confirmation that single-plex assays maintain performance in a multiplex format. It is possible that through the process of further analytical evaluation and the clinical validation, that it may be necessary to modify the final panel to be commercialized.
On Behalf of the Board of Directors
Dr. Jack Regan
Chief Executive Officer & Chairman
Corporate & Media Contact:
Director of Marketing
About LexaGene Holdings Inc.
LexaGene is a molecular diagnostics company that develops molecular diagnostic systems for pathogen detection and genetic testing for 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 MiQLab™ system delivers excellent sensitivity, specificity, and breadth of detection and can return results in approximately two hours. 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.