Successful Results Reported from Human Clinical Diagnostics Laboratory Beta Site

LexaGene Reports on Successful Results from Beta Testing in Human Clinical Diagnostics Laboratory

BEVERLY, Mass. – Sept 19, 2019 – LexaGene Holdings, Inc., (OTCQB: LXXGFTSX-V: LXG) (the “Company”), a biotechnology company that develops genetic analyzers for rapid pathogen detection and other molecular markers, announced today it has completed beta testing with Assurance Scientific Laboratories (ASL) in Vestavia, Alabama.  ASL is a certified reference laboratory specializing in providing clinical testing results to physicians nationwide.  The laboratory processes over 300 urine samples per week for human urinary tract infections – plus hundreds of other sample types.

Dr. Greer Massey, ASL’s Director of Molecular Diagnostics, comments, “We enjoyed using LexaGene’s technology.  Their staff has built a very easy-to-use instrument that allows for the detection of many different targets from a single sample extraction. We processed many complicated UTI samples containing multiple pathogens on their instrument and found good correlation between LexaGene’s assays and our semi-automated process. The ability to automate extraction and sample analysis with less than 1 min of hands-on time will allow for lower overhead expenses.  We look forward to moving to a process that eliminates micropipetting.”

Mary Beth Minyard, ASL’s Director of Microbiology, comments, “We’re interested in LexaGene’s technology not only for its ease-of-use as it automates sample prep, assay assembly, and assay performance, but also because its ‘open-access’ feature allows us to use our own assays.  Collectively, this integrated device drastically reduces our hands-on time. Being able to combine automated sample extraction and analysis at a reasonable price would be a huge selling point for us.”

LexaGene has now completed beta tests for urinary tract infections in both dogs and humans, uncovering very different infection profiles for both.  In comparison to the canine samples, the human samples were much more frequently infected with two or more pathogens – and the prevalence of antibiotic resistance genes was much higher.  These data support the recent New York Times articlethat described urinary tract infections as needing more advanced diagnostics to more quickly inform on antibiotic resistance rather than relying on the standard culture process – which takes days.

The Centers for Disease Control and Prevention (CDC) views antibiotic resistance as being one of the biggest public health challenges of our time,as it could cause 10 million deaths each year by 2050.As such, there is high demand for technologies that can improve antibiotic stewardship by providing in-hospital actionable information within an hour of initiating sample processing – and LexaGene’s technology meets this need.

Dr. Jack Regan, CEO and Founder of LexaGene states, “We are very pleased that our beta program is having such great success.  We expect this trend to continue as we work through the final stages of commercializing this technology.”

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1https://www.nytimes.com/2019/07/13/health/urinary-infections-drug-resistant.html
2https://www.cdc.gov/drugresistance/biggest_threats.html
3https://www.who.int/news-room/detail/29-04-2019-new-report-calls-for-urgent-action-to-avert-antimicrobial-resistance-crisis

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 process multiple samples at a time, in an on-demand fashion, returning 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.

About Assurance Scientific Laboratories
Assurance Scientific Laboratories (ASL) is comprised of a passionate team of medical doctors and scientists who believe in using the best objective data available to help health care providers make accurate and timely diagnoses. Our mission is to provide healthcare providers with Assurance to treat their patients in the best manner possible. We specialize in molecular, microbiology, and toxicology assays and technology.  For more information, visit Assurance Scientific Laboratories.

Media Contacts
Nicole Ridgedale
Director of Corporate Marketing, LexaGene
800.215.1824 ext 206
nridgedale@lexagene.com

Investor Relations
Jay Adelaar
Vice President of Capital Markets, LexaGene
800.215.1824 ext 207
jadelaar@lexagene.com

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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.