BEVERLY, Mass. USA – Aug 24, 2022 – LexaGene Holdings, Inc., (OTCQB: LXXGF; TSX-V: LXG) (“LexaGene” or the “Company”), an innovative, molecular diagnostics company that has commercialized the MiQLab® System for automated, genetic syndromic testing for veterinarians, announces it has successfully configured the MiQLab System to use isothermal chemistry for individual pathogen detection in as soon as 30 minutes, which complements our traditional real-time PCR chemistry for syndromic testing that provides results in as soon as 80 minutes.
Dr. Jack Regan, LexaGene’s Founder and CEO stated, “Today, we are excited to announce that our innovative, MiQLab System has the capabilities to use isothermal chemistry. The System generates results on positive samples within the time frame of a patient visit, empowering veterinarians to make evidence-based decisions before the dog or cat leaves the clinic.”
He continued, “There is a role for both isothermal testing and real-time PCR testing in clinical markets. Isothermal testing is great for quickly determining if a pathogen is present but may not provide information on the quantity of that pathogen, which is important for some applications. In syndromic applications where testing for more than 20 targets is required, real-time PCR is the preferred chemistry as it is easily multiplexed, quantitative and extremely sensitive. Due to the different needs of veterinarians, there is value in having a technology, like the MiQLab System, that can utilize both chemistries. To our knowledge, the MiQLab System is the first fully automated point-of-care system that can perform both chemistries allowing the veterinarian the option of a multiplexed real-time PCR test or a STAT isothermal Leptospira test or other pathogen tests currently being developed at LexaGene.”
Dr. Nathan Walsh, LexaGene’s VP of Applications and Bioinformatics, commented, “For isothermal testing, we first developed a test for Leptospira (the cause of leptospirosis) because it is in high demand from veterinarians. The CDC has acknowledged that without proper diagnosis and treatment, leptospirosis can lead to kidney damage, meningitis (inflammation of the membrane around the brain and spinal cord), liver failure, respiratory distress, and even death. The MiQLab System can now successfully detect Leptospira DNA in as little as 30 minutes when processing urine spiked with Leptospira genetic material.”
Leptospira is common in dogs and is one of the most difficult bacteria to culture. Growth is usually observed in 1 – 2 weeks but can take as much as three months.1 Additionally, culture is problematic because it uses a rich media that allows competing organisms to grow which hide the presence of Leptospira. The MiQLab System has the capabilities to detect these troublesome bacteria in as soon as 30 minutes without needing to culture.
LexaGene is working on additional validation and software improvements before this test becomes commercially available. We are evaluating the benefits of adding sample preparation prior to processing both whole blood and urine samples, as adding this step introduces a trade-off between time-to-result and the sensitivity and robustness of the test. It is possible these experiments will support adjusting the final time-to-result for a commercial test looking for Leptospira in both the blood and urine. At this time, we are aiming to have positive results available in as soon as 30 minutes, whereas negative results might not be available for 40+ minutes.
About LexaGene Holdings Inc.
LexaGene is a molecular diagnostics company that has commercialized the MiQLab System for fast and easy detection of pathogens and other molecular markers. The System is designed for on-site usage and uses real-time PCR chemistry. Our customers include veterinary hospitals and reference laboratories – as well as contract biologic manufacturers. The MiQLab System delivers excellent sensitivity, specificity, and breadth of detection.
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