LexaGene Completes Multi-Center Validation Study Using MiQLab® System for Diagnosing Urinary Tract Infections
BEVERLY, Mass., July 27, 2022 (GLOBE NEWSWIRE) — LexaGene Holdings, Inc., (OTCQB: LXXGF; TSX-V: LXG) (“LexaGene” or the “Company”), a molecular diagnostics company that has commercialized the MiQLab® System for automated PCR-based syndromic testing in veterinary clinics, provides a brief summary of preliminary data collected during a clinical validation study conducted at two of the top five veterinary universities in the nation.1
The study was led by Professor Dr. Jane Sykes BVSc (Hons), PhD, MBA, DACVIM (SAIM) at the University of California-Davis (UC Davis). Urine specimens were also tested in the laboratory of Dr. Stephen ColeMS, VMD at PennVet, University of Pennsylvania (UPENN). Each site operated a MiQLab System equipped with a MiQLab Bacterial and AMR Test V2, which screens samples for 10 common pathogens and 33 markers for antimicrobial resistance factors. MiQLab System data were compared to standard culture and susceptibility testing.
The study was conducted in prospective manner. A total of 105 urine specimens were tested across the two sites, of which, 39 were deemed to be clinically relevant for a urinary tract infection. The MiQLab System successfully detected all Escherichia coli, Staphylococcus, Proteus, Klebsiella, Enterococcus faecium, and Enterococcus faecalis positive samples. One positive Streptococcus sample was not detected. When the entire data set of successful runs were compiled the sensitivity of the MiQLab System using the MiQLab Bacterial and AMR Test V2 for detecting pathogens was 97%, specificity was 91%, agreement was 93%, and kappa agreement was 0.86 (almost perfect).
These data were presented in a live webinar last night at 7 PM ET. The webinar was hosted by DVM360 and moderated by Adam Christman, DVM, MBA. A recording of this webinar will be made available by DVM360 in approximately one weeks’ time on their website (https://ce.dvm360.com/)
Dr. Jack Regan stated, “We are very pleased by these data as they show the MiQLab System provides reference-laboratory quality results in just 2 hours rather than days. The results of this study allowed us to further refine the performance of both the instrument and diagnostic test components, such as the Streptococcus assay. The results of preliminary testing following these refinements are extremely positive.”
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 has commercialized the MiQLab® System for fast and easy detection of pathogens and other molecular markers. The System is PCR-based, screens for 24 targets at once, and is designed for on-site usage. 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 and returns results in approximately two hours. The MiQLab System is also open-access, which allows end-users to load their own PCR assays onto the System to target any genetic target of interest.
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