• MiQLab detected both bacterial strains in polymicrobial samples in ~2 hours
  
• Culture and Sensitivity Testing (C&ST) failed to detect the minor pathogen population in individual mixed samples, with final test results taking up to 11 days
• MiQLab testing can improve treatment decisions, particularly for infections caused by drug resistant strains
  

BEVERLY, Mass., Sept. 07, 2021 (GLOBE NEWSWIRE) -- LexaGene Holdings, Inc., (OTCQB: LXXGF; TSX-V: LXG) (“LexaGene” or the “Company”), a molecular diagnostics company that develops fully automated rapid pathogen detection systems, today announced it successfully utilized its MiQLab™ System (“MiQLab”) to detect the presence of multiple strains of pathogenic bacteria in polymicrobial samples that vary in their antimicrobial resistance (AMR). These samples were missed by traditional Culture and Sensitivity Testing (C&ST), and the time-to-results were orders-of-magnitude faster for the MiQLab.

Dr. Jack Regan, LexaGene’s CEO and Founder stated, “C&ST is viewed as the gold standard; however, it can generate false results^1,2,3 and can take too long for routine use. In this study, LexaGene demonstrates that PCR testing is far better at reliably detecting a mixed culture, which is critical for improving patient outcomes, particularly if the minor pathogen population is resistant to the prescribed therapy. Not only is the MiQLab better in this regard, but it also provides results in ~2 hours rather than 5 to 11 days as observed in our study for C&ST. These two advantages can be significant enough to persuade many to adopt in-clinic PCR testing for routine use in medical and veterinary care settings.”

An interview with Dr. Regan can be viewed HERE.

Polymicrobial infections can be defined as simultaneous or successive infections caused by two or more distinct microorganisms or genotypically different strains of the same pathogen in the same anatomical site. In the case of urinary tract infections (UTIs), there are reports that demonstrate as high as 39% of urine cultures in elderly patients show polymicrobial infections.⁴ Another study in veterinary medicine showed that 45% of the samples collected from companion animals were polymicrobial in nature and a high percentage were multi-drug resistant.⁵ A third study showed that polymicrobial infections can cause flesh-eating wounds.⁶

Dr. Manoj Nair, BVSc, MVSc, PhD, LexaGene’s Director of of Applications & Assay Development, stated, “I practiced as a veterinarian early in my career and found complicated and recurrent infections to be extremely frustrating for the pet owner and certainly distressing for the pet. The occasional failure of culture to detect the presence of polymicrobial infections may contribute to the challenge of successfully treating these infections after the initial visit. Having the MiQLab in clinics can help veterinarians to accurately diagnose even these troublesome infections and offer the best possible diagnostics and care to the clients.”

Two pathogens frequently seen in companion animal diseases are Staphylococcus pseudintermedius, which is typically associated with skin infections, and Escherichia coli, which is the leading cause of UTIs. We assessed the ability of the MiQLab, equipped with the Bacterial and AMR Test V2*, to detect the presence of subpopulations of antimicrobial resistance (AMR) pathogens in mixed samples in comparison to the current standard for microbial identification and antimicrobial sensitivity (reference laboratory C&ST).

Four bacterial strains were used in two groupings, the first group contained two S. pseudintermedius strains (one with, and one without AMR genes) and the second group contained two E. coli strains (one with, and one without an AMR gene). The strains with AMR genes were mixed at a 1,000-fold lower concentration than the strains without AMR genes to represent a subpopulation of AMR bacteria in the mixed sample. The original strains and each of the S. pseudintermedius and E. coli mixed samples were sent to two reference laboratories, one of which would be considered a market leader, for C&ST. All samples were concurrently run on the MiQLab using the Bacterial and AMR Test V2.

The MiQLab correctly identified Staphylococcus spp. and E. coli in the appropriate samples tested. Additionally, the MiQLab successfully detected the AMR markers associated with resistance to beta-lactams, lincosamides, sulfa-TMP, and tetracyclines in the minority population of the S. pseudintermedius mixed sample and an AMR marker associated with beta-lactam resistance in the minority population of the E. coli mixed sample. In comparison, both reference labs reported the correct species of bacteria in each sample tested but failed to correctly report the resistances associated with the subpopulation of AMR bacteria in the two mixed samples. Moreover, the MiQLab generated results in ~2 hours per sample versus 5 to11 days for the two reference labs, with the most well-known and respected reference laboratory taking the longest. Our results demonstrate the advantage the MiQLab system has over culture in detecting subpopulations of bacteria in polymicrobial samples with genotypic differences that can potentially affect treatment outcomes. Using this technology in clinic, where results are available in ~2 hours, would be expected to significantly improve treatment decisions.

*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

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.ncbi.nlm.nih.gov/pmc/articles/PMC3244596/
2. https://link.springer.com/content/pdf/10.1007/s10096-019-03499-x.pdf
3. https://www.sciencedirect.com/science/article/pii/S1198743X14605796#bib4 
4. Laudisio A, Marinosci F, Fontana D, et al. The burden of comorbidity is associated with symptomatic polymicrobial urinary tract infection among institutionalized elderly. Aging Clin Exp Res. 2015;27(6):805-812.
5. Fernández-Bravo A, Kilgore PB, Andersson JA, et al. T6SS and ExoA of flesh-eating Aeromonas hydrophila in peritonitis and necrotizing fasciitis during mono-and polymicrobial infections. Proc Natl Acad Sci. 2019;116(48):24084-24092.
6. Hartantyo SHP, Chau ML, Fillon L, et al. Sick pets as potential reservoirs of antibiotic-resistant bacteria in Singapore. Antimicrob Resist Infect Control. 2018;7(1):106.