BEVERLY, Mass. USA – Oct 13, 2022 – LexaGene Holdings, Inc., (OTCQB: LXXGF; TSX-V: LXG) (“LexaGene” or the “Company”), an innovative, molecular diagnostics company that has commercialized the MiQLab® System for automated, genetic testing, is pleased to announce that it has received an indication that a major biopharma company intends to purchase its technology.
Dr. Jack Regan, LexaGene’s CEO and Founder stated, “We are excited to report a major international biopharma manufacturer has provided us a signed quote for the purchase of a MiQLab System. We’ve also discussed assisting them in their validation to speed up the timeline for determining whether the MiQLab System will meet their significant manufacturing testing needs.”
He continued, “This second sale into this industry has dramatically boosted our optimism for the biopharma market, where a single manufacturing plant would potentially purchase 25 or more systems. Our very first sale happened to be to another major international biologic manufacturer. This company completed their initial validation, which was significantly drawn out due to staffing issues. Nonetheless, they have continued to express enthusiasm for the technology, and we remain hopeful that adoption into their manufacturing process is the next step, where presumably numerous systems would be needed to meet their testing requirements.”
Contamination testing in the biopharmaceutical space was estimated to be a ~$10B market opportunity in 2021 with approximately 350 million tests run annually.1 Biopharmaceutical companies frequently test for contamination to avoid having a recall, as these events can cost tens of millions of dollars in investigation, cleanup, corrective actions, lost revenue, and manufacturing plant downtime.2,3
The list of possible biopharma contaminants is long, with many requiring custom culture conditions for optimal growth. Even under optimal growth conditions, some contaminants take up to 28 days for testing.4 In contrast, PCR-based testing does not require specialized culture conditions and can be performed immediately – providing results in hours rather than weeks. The time savings that can be realized, using the MiQLab System, can have massive implications for biopharmaceutical manufacturers by allowing them to quickly identify contaminants before the contamination results in massive losses.
The biopharma industry is increasingly looking for flexible PCR solutions to handle complex matrices, screen for numerous targets, and report results quickly. These requirements make LexaGene’s technology an ideal solution. LexaGene’s MiQLab System has already been tested and proven to work well on some of the most common cell lines and products manufactured 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 pathogens and other molecular markers. The System is designed for on-site usage and uses real-time PCR chemistry. 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.
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.
 Liu, S. et al. Development and qualification of a novel virus removal filter for cell culture applications. Biotechnol. Prog. 16, 425–434 (2000).