- Mycoplasmas are thought to contaminate 15-80% of cell cultures worldwide
- MiQLab rapidly detected 100% of the tested mycoplasma samples within two hours, with no false positives
- MiQLab can be used inside biopharmaceutical manufacturers to rapidly validate their products as being free and clear of mycoplasmas
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
Bioprocessing can be broadly defined as the utilization of living organisms to manufacture biological-based products.1 The bioprocessing workflow can be broken down into three stages: upstream, harvest, and downstream.2 The upstream aspect involves setting up culture conditions to maximize cellular growth. Once cells reach a high enough concentration, they are harvested so that biological product can be extracted, isolated, concentrated, and purified to make the final product.
Mycoplasmas are thought to contaminate 15 to 80 percent of cell cultures worldwide.3 Common methods for mycoplasma detection are extremely 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
LexaGene’s MiQLab Mycoplasma Test is designed to detect the most relevant mycoplasma species for microbial contamination in bioprocessing, specifically Mycoplasma arginini, Mycoplasma orale, Mycoplasma hyorhinis, Mycoplasma fermentans, as well as Acholeplasma laidlawii.6
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.
To learn more about LexaGene and the MiQLab System, subscribe to company updates, visit www.lexagene.com, or follow us on Twitter or LinkedIn.
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 two hours. 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.
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.
2. Clapp KP, Castan A, Lindskog EK. Chapter 24 - Upstream Processing Equipment. In: Jagschies G, Lindskog E, Łącki K, Galliher PBT-BP, eds. Elsevier; 2018:457-476.
3. Nikfarjam L, Farzaneh P. Prevention and detection of Mycoplasma contamination in cell culture. Cell J. 2012;13(4):203-212.
4. https://www.biopharminternational.com/view/usp-mycoplasma-tests-new-regulation-mycoplasma-testing
5. Barone PW, Wiebe ME, Leung JC, et al. Viral contamination in biologic manufacture and implications for emerging therapies. Nat Biotechnol. 2020;38(5):563-572.
6. Kong F, James G, Gordon S, Zelynski A, Gilbert GL. Species-specific PCR for identification of common contaminant mollicutes in cell culture. Appl Environ Microbiol. 2001;67(7):3195-3200.