LexaGene Completes Pilot Clinical Study and Reports Results

LexaGene Completes Pilot Clinical Study and Reports Results

LexaGene Analyzer is 97.5% Concordant with Reference Laboratory Generated Data and Will Take Just One Hour Versus 2 – 5 Days to Return Results

BEVERLY, Mass. – Feb 25, 2019 – LexaGene Holdings Inc. (OTCQB: LXXGF; TSX-V: LXG) (the“Company”), a biotechnology company that develops genetic analyzers for pathogen detection and other molecular markers, announced today that as part of the Company’s previously announced pilot clinical study, the LX genetic analyzer technology, in a fully automated manner, successfully detected all six of the known pathogens in 107 canine urine samples tested.

Previously, the Company announced that the LX technology successfully detected dual infections and pathogens harboring antibiotic resistance factors. On completion of the clinical study, the Company now confirms that the LX analyzer technology has robustly – in a sensitive and specific manner – detected each of the six most common pathogens in canine urinary tract infections (UTI) and is 97.5% concordant with reference laboratory generated results.

Dr. Jack Regan, LexaGene’s CEO and Founder states, “This is a monumental moment for the organization, as we have concluded our pilot study and are extremely pleased with the performance of the LX analyzer. I am very proud of the compelling data, and the hard work that went into validating the LX technology. This news represents the tip of the iceberg for what is to come from LexaGene as we continue to demonstrate how our technology outperforms the current standard for testing.”

Highlights of the generated data are as follows.

  • 107 urine samples processed in a blinded fashion (samples provided by Ethos Veterinary Health)
  • Each of six major pathogens was successfully detected (E. coli (43), Staphylococcus (11), Proteus (11), Enterococcus (8), Klebsiella (2), and Streptococcus (1)), which are amongst the most common pathogens found in canine UTI
  • 97.5% concordance with reference laboratory generated data for the 642 tests performed for the study (6-pathogen assays tested per sample)*
  • Successfully detected some dual-infected samples
  • Successfully detected some bacteria harboring antibiotic resistance factors
  • Correctly identified 21 urine samples collected from dogs without urinary tract infections that were determined to be pathogen negative

The only commercially available technology available to veterinarians for rapid in-house testing is based on antibody tests. These tests do not identify the causative pathogen, do not provide guidance on which antibiotic to prescribe, and have just 46% sensitivity.** As a result, veterinarians generally still send their samples to a reference laboratory for testing, which takes 2 – 5 days to return results, and this delay can negatively impact the quality of care.

LexaGene’s LX genetic analyzer will solve these problems by providing the first technology for in-hospital use that provides rapid, sensitive, and broad-spectrum testing, which will help veterinarians reduce morbidity and mortality rates, lower healthcare costs, and improve antibiotic stewardship.

Dr. Sam Stewart, DVM, DACVECC, an emergency and critical care veterinarian at Boston West Veterinary Emergency and Specialty hospital in Natick, MA, states, “I am pleased to hear of the success from LexaGene’s UTI study. The LX technology will be a game changer for veterinary care. Having this capability to rapidly diagnose a patient – and get information on antibiotic resistance – while they are still in our facility rather than waiting days for a reference laboratory generated result will allow us to improve our quality of care dramatically.”

Dr. Chand Khanna DVM, PhD, DACVIM (Onc), DACVP (Hon), Chief Science Officer of Ethos Veterinary Health and President of Ethos Discovery added, “This LexaGene technology brings veterinary medicine into the point-of-care and molecular diagnostic era. We look forward to the use of this technology to rapidly determine whether a dog has a urinary tract infection. If LexaGene’s test comes back with a negative result, we can order additional tests to rule out many complex medical problems that all manifest with similar symptoms.” He continues, “This technology will raise the level of care provided by veterinary medical teams to their patients.”

Dr. Jack Regan concludes, “These initial data are excellent and we expect to further improve our performance as we get closer to product launch. These data indicate that our technology will be able to generate results similar to a reference laboratory, with vastly improved turnaround times. We look forward to launching this product so veterinary hospitals can adopt our next-generation diagnostic analyzer to lessen their dependence on reference laboratories for their pathogen testing needs.”

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* Samples producing discordant results are being further investigated by appropriate methods including Sanger sequencing to determine whether data from the LX prototype or the reference laboratory is correct.

**When processing samples that have 103 CFU/ml. (source)

About LexaGene Holdings Inc.

LexaGene is a biotechnology company commercializing the very first easy-to-use, fully automated, genetic analyzer that is open-access. The open-access feature empowers end-users to target any genetic sequence of interest, whether of pathogen or human origin. To take advantage of the open- access feature, end-users simply need to load their own real-time PCR assays onto the instrument tocustomize their tests or run validated assays the company is developing. LexaGene’s analyzers offerexcellent sensitivity, specificity, and breadth of pathogen detection while returning results in about 1 hour. The company expects to sell its technology in the food safety and veterinary diagnostics markets, as well as to markets that need easy-to-use customized testing such as biotechnology and pharmaceutical companies, academia, and institutions performing water quality monitoring, aquaculture pathogen surveillance, and others.

About Ethos Veterinary Health

Ethos is a veterinary health company with hospitals across the U.S. providing advanced specialty medical care for pets. Our approach includes a focus on transformative science, continuous learning, growth for team members, and collaboration. For more information, please visit ethosvet.com.

About Ethos Discovery

Ethos Discovery is a 501(c)3 non-profit incubator of scientific innovation that seeks to improve health outcomes in pets and humans with complex medical problems, including cancer. For more information, please visit www.ethosdiscovery.org.

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.


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