BEVERLY, Mass. USA – July 2, 2021 – LexaGene Holdings, Inc., (OTCQB: LXXGF; TSX-V: LXG) (the “Company”), a molecular diagnostics company that develops fully automated rapid pathogen detection systems, today announced it continues to systematically advance the MiQLab™ System to meet the Food and Drug Administration (FDA) criteria for Emergency Use Authorization (EUA). The MiQLab System is a first of its kind, point of care diagnostic testing technology.
The FDA EUA process requires novel diagnostic devices to undergo a substantial amount of complex design control and testing. All functions for critical system operation must be validated and submitted as part of the process.
Dr. Jack Regan, LexaGene’s Founder and CEO stated, “The MiQLab systems we’ve sold into veterinary diagnostics and the biologics manufacturing market are in the field and working as designed. Part of our strategy is to use these systems in real-world settings, processing complex samples, to ensure our technology is ready to pass the stringent FDA requirements. The intent of the FDA requirements is to ensure vendors take the necessary steps to get the highest quality product possible out of their specific technology. Over the last few months, LexaGene has made great progress and completed many of these requirements. Namely, we have passed electrical safety testing, passed ship testing, finalized our master mix and carrier fluid formulation, finalized our test assays and their configuration, finalized our internal amplification control and internal process control, and completed our user manual to a state acceptable for an EUA submission.”
Steve Armstrong, LexaGene’s Chief Operational Officer, stated, “We are making great strides on the remaining requirements. Namely, we are in the process of verifying our longer reagent shelf-life (i.e., stability of our on-board reagents). We are also working on completing system software validation, including error handling. We’ve also been working on verifying an automated microfluidic scheduler as well as further refining our standard scripts for automated sample preparation and assay assembly. We continue work required to verify our thermal and optical parameters for optimal PCR amplification. Likewise, we are working on validating our signal processing algorithm and ensuring our reports are consistently accurate. Finally, we are making process improvements so we can scale manufacturing. Once the Company fully completes these necessary steps, the MiQLab will be fully optimized and ready for analytical and point-of-care clinical validation for EUA submission.”
Mr. Armstrong continued, “Coronavirus continues to present a real danger in the United States and internationally. The MiQLab is perfectly positioned to address this large and critically important market. LexaGene is eager to complete the FDA requirements as quickly as possible. To date, no novel fully integrated sample-to-answer, multiplex technology has made it through the EUA application process. LexaGene’s MiQLab may be the first. For our EUA application, we are taking a very methodical approach to this work. We look forward to the day when the MiQLab is being used as a valuable asset in the fight against COVID-19 and its deadly variants.”
The Company will periodically provide progress updates on our FDA EUA work.
The Company is not making any express or implied claims that its product has the ability to eliminate, cure, or contain the COVID-19 (or SARS-2 coronavirus) at this time. Also, despite the optimism management has regarding the potential of getting the MiQLab approved for EUA by the FDA for COVID-19 testing in humans, there is no guarantee the FDA will grant such approval.
On Behalf of the Board of Directors
Dr. Jack Regan
Chief Executive Officer & Chairman
Director of Corporate Marketing
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.
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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.