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LexaGene’s Largest Study Validates Accuracy of its


Technology Accurately Identifies Pathogens and Predicts Antimicrobial Resistance

  • In less than 30 years, drug resistant bacteria are predicted to kill 3 times more people on an annual basis than COVID-19 did in 2020
  • MiQLab is a diagnostic tool used for detecting drug resistance at the point of care which will allow veterinarians to provide quality care for patients with suspected bacterial infections
  • LexaGene’s MiQLab’s overall percent agreement in study:
    • >99% for pathogen identification (106 samples)
    • >96% for drug resistance markers in sequenced CDC bacterial strains (32 samples)
    • >92% for drug resistance phenotype in canine urinary isolates with culture-based drug resistance profiles (74 samples)

BEVERLY, Mass., Oct. 07, 2021 (GLOBE NEWSWIRE) — 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 and biopharmaceutical manufacturing, today announced, it successfully utilized its MiQLab™ System to correctly identify bacteria and determine the presence of antimicrobial resistance (AMR) markers that predict resistance to commonly prescribed first-line veterinary antibiotics.

Decades of over-use of antibiotics have resulted in a drastic rise in pathogens that are very difficult to treat due to their rapid evolution to resist the ‘killing’ effect of prescribed therapies. The problem has become so prevalent, and very few new drugs are in development, that the CDC predicts antimicrobial resistant pathogens will kill more than 10 million people per year in less than 30 years.1 To put this into perspective, over 3 million people died of COVID-19 in 2020,2 which would equate to just one-third of the yearly expected impact from drug resistant bacteria. The pandemic appears to have potentially accelerated these grim projections, as drug resistant infections have risen sharply during the pandemic and contributed to increased mortality.2,3 Providers have been slow to implement changes in drug prescription practices due to a lack of technologies that quickly inform on drug resistance at the point-of-care.

At the largest veterinary trade shows in September, LexaGene was the only company exhibiting with a product capable of rapid pathogen identification and AMR detection at the point-of-care, and accordingly the technology was met with much enthusiasm.

Dr. Jack Regan, LexaGene’s CEO and Founder stated, “The results from this study prove that the MiQLab is extremely accurate. LexaGene’s MiQLab has already started to help veterinarians with evidence-based decision making at the point-of-care, and these actions are critical to averting the grim projections on the number of future deaths due to AMR pathogens. We are happy that we are gaining momentum in veterinary diagnostics and expect our technology to eventually be considered a ‘must-have’ for veterinary hospitals interested in offering best-in-class service.”

He continued, “Published veterinary studies report that as little as 18 percent5,6,7 of urine samples taken from animals suspected of having a urinary tract infection (UTI) test positive for pathogens, but getting this information typically takes ~ 5 days. Many veterinarians are unwilling to wait this long for test results as an untreated urinary tract infection can lead to significant complications. As such, most veterinarians empirically prescribe drugs to pets suspected of having an infection because they are fearful of not treating a potentially dangerous infection. Such over-use of antibiotics has increased the prevalence of drug resistant pathogens and veterinarians are now increasingly caring for patients with unresolved infections, which can sometimes lead to euthanizing a pet, which contributes to caregiver depression.8”

LexaGene is proud to offer veterinarians the MiQLab System as a solution to minimize the number of unresolved infections, which we believe, will not only helps save the lives of animals, but also improve the morale of veterinarians who tirelessly care for our companion pets.

About the Study
The study used two sets of bacterial pathogens. The first set consisted of 32 sequenced strains from the CDC Antibiotic Resistance Isolate Bank.9

The second set included 74 bacterial isolates from dogs with urinary tract infections. These isolates were not sequenced and have only culture-based drug resistance profiles associated with them.

MiQLab Systems, equipped with MiQLab Bacterial and AMR Test V2* panels, recorded 100% and 99.1% overall percent agreements for pathogen identification for the sequenced CDC pathogens and the non-sequenced canine UTI isolates, respectively. Likewise, the MiQLab recorded 96.2% and 92.5% overall percent agreements for antimicrobial resistance for the sequenced CDC pathogens and non-sequenced canine UTI isolates for which only culture data is available, respectively.

An in-depth version of these data is being compiled for a peer-reviewed publication.

*MiQLab Bacterial and AMR Test V2 detects 10 common pathogens and 33 genes and variants that confer resistance to four classes of antimicrobials (beta-lactams, lincosamides, sulfa-TMP, and tetracyclines).

To learn more about LexaGene and the MiQLab System or subscribe to company updates, visit www.lexagene.com, or follow us on Twitter or LinkedIn.

On Behalf of the Board of Directors
Dr. Jack Regan
Chief Executive Officer & Chairman

Corporate & Media Contact:
Gail Winslow
Director of Corporate Marketing
gwinslow@lexagene.com
978.482.6237

ir@lexagene.com
800.215.1824

Investors:
Sharon Choe
Vice President
LaVoieHealthScience
schoe@lavoiehealthscience.com
(857) 241-7393

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.

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.

1) https://www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-report-508.pdf

2) https://news.yahoo.com/drug-resistant-infections-us-risen-153759696.html?soc_src=social-sh&soc_trk=ma&guccounter=1

3) https://news.yahoo.com/drug-resistant-infections-us-risen-153759696.html

4) https://www.who.int/data/stories/the-true-death-toll-of-covid-19-estimating-global-excess-mortality

5) https://pubmed.ncbi.nlm.nih.gov/24158327/

6) https://pubmed.ncbi.nlm.nih.gov/11467591/

7) https://pubmed.ncbi.nlm.nih.gov/25249356/

8) https://www.cdc.gov/media/releases/2018/p1220-veterinarians-suicide.html

9) Antibiotic Resistance Isolate Bank. Atlanta (GA): CDC. https://wwwn.cdc.gov/arisolatebank/

LexaGene Holdings Inc



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