LXG Lexagene Holdings Inc

LexaGene Holdings, Inc., (OTCQB: LXXGF; TSX-V: LXG) (“LexaGene” or the “Company”), an innovative, molecular diagnostics company that has commercialized the MiQLabTM System for automated, genetic testing, is pleased to announce exciting news regarding the ability of the MiQLab System to detect Mycoplasma at minute levels.

Dr. Jack Regan, CEO and Founder of LexaGene commented, “In the process of completing the follow-on feasibility study with one of our biopharma customers, I’m thrilled to report that through this work, we’ve made an ~500X improvement in sensitivity for Mycoplasma. We’ve communicated this achievement, plus other development milestones, to our biopharma customers, who have in turn expressed great enthusiasm."

Mycoplasma contaminates 15 – 80% of U.S. laboratory cell cultures.1 Confirming a culture or a biopharmaceutical biologic is negative for contaminating Mycoplasma takes 28 days by compendial methods.2 This delay not only shortens the time available to sell the product before expiration, but also puts the biopharma company at more risk during the 4 – 6 weeks of bioreactor growth. At these latter stages, often 10’s of millions of dollars’ worth of product is at risk should a contamination be detected. Furthermore, it is critical for biopharmaceutical manufacturers to have robust procedures for monitoring and controlling the biosafety of their processes to ensure patient safety and compliance.

The industry is looking to adopt an easy-to-use PCR-based technology that can be operated inside the manufacturing plant which provides extremely sensitive detection in just a few hours. Manufacturers want the ability to detect contaminations in raw materials and across each bioprocessing step, especially the most expensive and value-adding steps. The data generated for this feasibility study demonstrates LexaGene’s MiQLab System can be easily configured for extremely sensitive applications such as detecting Mycoplasma. This feasibility study adds to the body of data we’ve already generated that gets us closer to having our technology adopted for the manufacturing stage of producing biologics.

Dr. Regan continued, “Now that we have completed the follow-on feasibility study, we are in the process of discussing next steps with our biopharma customer. I will share updates as they become available.”

For more information about LexaGene and the MiQLab System, please visit www.lexagene.com or follow us on Twitter and LinkedIn.

About LexaGene Holdings Inc.        LexaGene is a molecular diagnostics company that has commercialized the MiQLab System for fast and easy detection of biological contaminants, pathogens and other molecular markers. The System is designed for on-site usage and uses real-time PCR chemistry. Our customers include biopharmaceutical companies and veterinary hospitals. The MiQLab System delivers excellent sensitivity, specificity, and breadth of detection.

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Except for statements of historical fact, this news release contains certain "forward-looking information" or "forward-looking statements" (collectively, "forward-looking information") within the meaning of applicable securities law. Forward-looking information is frequently characterized by words such as "plan", "expect", "project", "intend", "believe", "anticipate", "estimate" and other similar words, or statements that certain events or conditions "may" or "will" occur and include statements relating to our expectations regarding future results. Although we believe that the expectations reflected in the forward-looking information are reasonable, there can be no assurance that such expectations will prove to be correct. We cannot guarantee future results, performance or achievements. Consequently, there is no representation that the actual results achieved will be the same, in whole or in part, as those set out in the forward-looking information.

Forward-looking information is based on the opinions and estimates of management at the date the statements are made, including assumptions with respect to American economic growth, demand for the Company's products, the Company's ability to produce and sell its products, sufficiency of our budgeted capital and operating expenditures, the satisfaction by our strategic partners of their obligations under our commercial agreements, our ability to realize upon our business plans and cost control efforts and the impact of COVID-19 on our business, results and financial condition.

Our forward-looking information is subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those anticipated in the forward-looking information. Some of the risks and other factors that could cause the results to differ materially from those expressed in the forward-looking information include, but are not limited to: uncertainty as to whether our strategies and business plans will yield the expected benefits; uncertainty as to the timing and results of development work and verification and validation studies; uncertainty as to the timing and results of commercialization efforts; uncertainty as to our ability to supply products in response to customer demand; uncertainty as to the likelihood and timing of any required regulatory approvals, and the availability and cost of capital; the ability to identify and develop and achieve commercial success for new products and technologies; competition from related products; the level of expenditures necessary to maintain and improve the quality of products and services; changes in technology and changes in laws and regulations; our ability to secure and maintain strategic relationships; intellectual property infringement risks, risks relating to any required regulatory approvals, risks relating to the safety and efficacy of our products, the use of our products, intellectual property protection, risks related to the COVID-19 pandemic and its impact upon our business operations generally, including our ability to develop and commercialize our products, and the other risk factors disclosed in our filings with the SEC and under our profile on SEDAR at www.sedar.com. Readers are cautioned that this list of risk factors should not be construed as exhaustive.

The forward-looking information contained in this news release is expressly qualified by this cautionary statement. We undertake no duty to update any of the forward-looking information to conform such information to actual results or to changes in our expectations except as otherwise required by applicable securities legislation. Readers are cautioned not to place undue reliance on forward-looking information.

[1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3584481/

[2] https://www.biopharminternational.com/view/usp-mycoplasma-tests-new-regulation-mycoplasma-testing

 

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