BEVERLY, Mass. USA – Feb 8, 2023 – 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 provide the following update on the Company’s efforts to have the MiQLab System adopted for routine testing during the manufacturing of biologics.
Dr. Jack Regan, CEO and Founder of LexaGene commented, “We continue to work with both of our biopharma customers – a more traditional biopharma company with a market cap that is >$100B and a leading Contract Drug Manufacturing Organization (CDMO) with a market cap that is >$40B. Individuals in both organizations have indicated that our technology has the potential to benefit their respective companies and that our technology can be of great value to the entire industry.”
He continued, “We have sold our technology into the R&D groups of both companies. Although this is a critical first step, our goal is to get into manufacturing where regular testing at an average-sized plant could generate ~ $5M in revenue per year, and the entire annual testing market opportunity is estimated to be $10B in size.1
For our traditional biopharma customer, the execution of the feasibility studies was a great start and they have set aside time in April to start to a formal campaign within their facility that will focus on using the MiQLab System in the optimization of different manufacturing unit operations. These studies will include testing for Mycoplasma.
Per request from this customer, we have designed highly sensitive, RNA-based assays for bacteria (including Escherichia coli) and Minute Virus of Mice (MVM), and we are about to start designing an assay for Vesivirus 2117, as these contaminants are of highest interest for them.
During our conversations with our traditional biopharma customer, they suggested presenting at the 2023 National Institute for Innovation in Manufacturing Biopharmaceuticals (“NIIMBL”) National Meeting being held in June in Washington, DC. NIIMBL is a public-private partnership whose mission is to accelerate biopharmaceutical innovation and advance other industry objectives.
Our CDMO customer is in the process of submitting the data they’ve generated using a MiQLab System for a presentation at the 15th Annual Bioprocessing Summit, which is to be held in August in Boston, MA. The title of their talk is “Risk Reduction by Rapid Automated Detection of Common Biomanufacturing Contaminants.”
Dr. Regan concluded, “Having our biopharma customers request to present the data they generated using our technology at a conference is a fantastic endorsement and there is no better advertising. This exposure will help LexaGene achieve better brand awareness and wider adoption in the industry.”
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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 Rapid Micro Biosystems, 2021 10-K SEC filing, filed 03/24/2022