LexaGene's MiQLab Detects Common Bioreactor Contaminant up to 300 Times Faster than Conventional Methods
BEVERLY, Mass., July 20, 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 has successfully utilized its MiQLab™ System (“MiQLab”) to detect the presence of mycoplasmas, a group of common microbial contaminants responsible for substantial losses in both time and money for biopharmaceutical manufacturers.
Dr. Jack Regan, LexaGene’s CEO and Founder stated, “We are increasingly harnessing the power of our MiQLab to drastically shorten the time-to-result for microbial biopharmaceutical contamination detection. Last month, LexaGene announced it could detect Cutibacterium acnes 36 to 168 times faster than conventional methods. Through our research and development efforts, MiQLab technology can now readily detect mycoplasmas, a group of pervasive and highly problematic contaminants. We expect the time benefit of MiQLab Mycoplasma Test to be up to 300 times faster than conventional methods. These findings are significant for biopharmaceutical manufacturers and other life science companies. We are aggressively developing more tests for this industry so we can provide them a complete solution for their contamination testing needs.”
A brief interview with Dr. Regan may be viewed here.
About Bioprocessing and Mycoplasmas
Mycoplasmas are thought to contaminate 15 to 80 percent of cell cultures worldwide.3 Common methods for mycoplasma detection are xtremely slow, taking approximately 28 days for definitive results.4 Routine microbial contaminant testing during bioprocessing is imperative to maintain control over product yield, quality, safety, efficacy, and to correctly identify microbial contamination. Reducing the time to result is crucial to allow companies to make swift and precise decisions. There are significant financial implications for a mycoplasma contamination event, where examination and decontamination procedures, corrective actions, product shortages, and damages to the manufacturers brand can lead to millions of dollars spent per incident.5
LexaGene’s MiQLab Mycoplasma Test and Test Results
To validate the ability of the MiQLab Mycoplasma Test to accurately detect mycoplasmas, while dramatically reducing time to result, mycoplasma strains (M. arginini, M. cynos, and A. laidlawii) were spiked into a selective medium and incubated under appropriate growth conditions where a color change of the medium represented presumptive detection of microbial growth. These samples were harvested and processed on a MiQLab, which successfully detected all the samples with 100 percent accuracy. Future studies will determine the limit of detection for the Mycoplasma Test.
To test the specificity of the Mycoplasma Test, very high concentrations of common contaminants (Escherichia coli, Staphylococcus aureus, Streptococcus agalactiae, and Cutibacterium acnes) were run on the MiQLab. Cultures were incubated and grown between 24 to 72 hours, diluted 10-fold, and run on the MiQLab, which reported no false positives, validating very high specificity for the Mycoplasma Test.
LexaGene’s results demonstrate that the MiQLab system can serve as a valid alternative to lengthy traditional methods for mycoplasma detection. Given the MiQLab can be up to 300 times faster than traditional culture testing (~2 hours versus ~28 days) for a definitive result, the MiQLab can provide a significant time advantage for biopharmaceutical manufacturers.
On Behalf of the Board of Directors
About LexaGene Holdings Inc.
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. Cossar D. Bioprocessing techniques. Published online 2019.
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