- MiQLab is sensitive enough to detect the vast majority of clinical infections caused by target organisms
- ~100% positive percent agreement with culture data on processed canine urine samples
- ~99% negative percent agreement with culture data on processed canine urine samples
- ~99% overall percent agreement with culture data on processed canine urine samples
- Detected Staphylococcus in 21 of 23 (91%) specimens from skin infections in a correlation study
- Detected the mecA gene in 8 of 9 (89%) specimens that contained methicillin resistant Staphylococcus
- Quantitative data on par with culture (r2 ~0.95)
BEVERLY, Mass. USA – April 14, 2021 – LexaGene Holdings, Inc., (TSX-V: LXG; OTCQB: LXXGF) (the “Company”), a molecular diagnostics company that develops fully automated rapid pathogen detection systems, is pleased to host a private event for a select group of veterinarians that will feature keynote speaker Dr. Shelley Rankin, Professor of Microbiology at the University of Pennsylvania’s School of Veterinary Medicine (Penn Vet), who will present data on her experience using LexaGene’s MiQLab to detect Staphylococcus in specimens collected from canine skin infections. In addition, Dr. Jack Regan, LexaGene’s CEO and Founder, will provide some introductory remarks on the use of molecular diagnostics in veterinary medicine and present some analytical and clinical data generated using LexaGene’s MiQLab system. Any information thought to be of material nature for this seminar is described below.
To demonstrate the performance of LexaGene’s MiQLab to detect common bacterial pathogens encountered in veterinary medicine, Dr. Rankin and LexaGene teamed up to perform a series of analytical and clinical studies. For the analytical studies and clinical urine study, MiQLabs were equipped with LexaGene’s MiQLab™ Bacterial and AMR Test, which screens samples for 7 of the most common bacterial pathogens found in companion animals, as well as 13 different antimicrobial resistance factors.
Dr. Rankin’s evaluation focused on skin and soft tissue infections in dogs, which are commonly caused by Staphylococcus pseudintermedius (SP) and Staphylococcus schleiferi (SS). Treating these infections using empiric therapy is a challenge because it has been shown that up to 59% of SP isolates from canine pyoderma can harbor the mecA gene, which confers resistance to all beta-lactam drugs.1 Rapid in-clinic molecular diagnostics that can detect Staphylococcus and the presence of the mecA gene will, in most cases, allow veterinarians to prescribe an appropriate antibiotic. It is well known that antibiotic use can contribute to the problem of drug resistance in bacteria and inappropriate use of antibiotics is highly discouraged in veterinary medicine. For that reason, it is very important to know quickly if the mecA gene is present in the Staphylococcus species causing the infection. For this study, 23 skin specimens, that were confirmed by culture to contain SP or SS, were tested with the MiQLab. Staphylococcus was detected in 21 of these specimens (91%). Similarly, antimicrobial susceptibility testing showed the MiQLab detected the mecA gene in 8 of 9 (89%) of the Staphylococcus isolates that were cultured and found to be resistant to methicillin. These data signify that veterinarians using MiQLab in their clinic can prescribe therapy with confidence based on genetic analysis. This will improve clinical outcomes and minimize the development of drug resistant bacteria.
Dr. Rankin comments, “LexaGene’s MiQLab returns a molecular analysis on specimens in a fraction of the time it takes for culture to return results. As a result, veterinarians using MiQLab can rule-out, or rule-in, infection and therefore offer pet owners evidence-based treatment decisions for their pets on the same day of the clinical appointment. In this day and age, when antibiotic resistance is common in many veterinary pathogens, veterinarians are looking for new technologies to minimize the use of unnecessary or non-efficacious antibiotics and improve patient outcomes.”
LexaGene’s staff completed a second clinical study that focused on detecting the pathogens responsible for urinary tract infections in cats and dogs. For this study, 51 frozen canine urine samples (25 positive and 26 negative samples) that were previously tested by culture were processed on MiQLab. Six different pathogens were detected from the processed samples, including 14 E. coli, 7 Staphylococcus, 5 Enterococcus, 3 Streptococcus, and 1 Enterobacter. Three of the samples contained antimicrobial resistance factors. The MiQLab test results had a positive percent agreement of 100% (95% CI: 88.7% – 100%), negative percent agreement of 98.5% (95% CI: 96.5% – 99.3%) and overall percent agreement of 98.6% (95% CI: 96.8% – 99.40%), with culture.
LexaGene’s staff also completed two analytical studies. The first was performed to determine the MiQLab’s limit of detection (LoD) for the most common pathogen responsible for urinary tract infections in cats and dogs, namely Escherichia coli. In this study, a total of 28 samples were processed on four different MiQLabs and the LoD was determined to be 1×104 colony forming units per milliliter (cfu/mL) for E. coli. This LoD is low enough to detect the vast majority of infections considered to be clinically relevant.2 Furthermore, these data can be quickly generated inside the clinic, avoiding the 24 hr+ time it takes to get results back when samples are shipped to a reference laboratory for testing.
The second analytical study looked to provide insight into how the semi-quantitative nature of the MiQLab correlates to the cfu measurements reported when samples are cultured. For this study, E. coli and Proteusmirabilis samples were tested in 5-point log-scale dilution series from 5×103 to 7×108 cfu/mL. MiQLab generated Cycle of Quantification (Cq) values were correlated to culture cfu/mL counts and fit to a linear curve, and the calculated regression coefficients (r2) were found to be 0.96 and 0.94, respectively for E. coli and P. mirabilis. These data signify that the Cq values reported by the MiQLab correlate extremely well with the cfu/mL counts provided from traditional culture methods, which can be useful for tracking whether an administered antibiotic is having the desired effect.
Dr. Jack Regan concludes, “Our goal has always been to have the MiQLab generate high quality data inside veterinary clinics where veterinarians can use this data to guide treatment decisions. These data prove we have achieved this goal. Our sales team will be using these data to secure sales in the veterinary market, which has relatively few options for quality in-hospital pathogen testing.”
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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 one 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.
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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.
1 Lynch SA, Helbig KJ. The Complex Diseases of Staphylococcus pseudintermedius in Canines: Where to Next?. Vet Sci. 2021;8(1):11. Published 2021 Jan 18. doi:10.3390/vetsci8010011
2 Weese, J.S., Blondeau, J.M., Boothe, D. et al. Antimicrobial use guidelines for treatment of urinary tract disease in dogs and cats: antimicrobial guidelines working group of the international society for companion animal infectious diseases. Veterinary Record 2011. doi: 10.4061/2011/26376