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 results1,2,3 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).

Source: Company Press Release