LexaGene Provides a Corporate Update
BEVERLY, Mass. USA – Oct 5, 2020 – LexaGene Holdings, Inc., (TSX-V: LXG; OTCQB: LXXGF) (the “Company”), a molecular diagnostics company that develops fully automated rapid pathogen detection systems, is pleased to provide a general corporate update.
LexaGene aims to become the first company to sell a fully automated, highly multiplexed, open-access, sample-to-answer system for pathogen detection that is useful across multiple markets. The Company’s primary markets are veterinary and human clinical diagnostics, food safety, and markets that have custom genetic testing needs, which it refers to as open-access markets.
LexaGene’s treasury currently stands at $11.3M USD ($14.9M CDN), putting the Company in a strong position to support its development goals for the next year and more.
Dr. Jack Regan, LexaGene’s Founder and CEO, states, “Our MiQLab™ pathogen detection system has 230 unique components. Over the summer, the coronavirus pandemic caused some supply chain issues for several key components that delayed the manufacturing, optimization and testing of these systems. Just recently, these supply chain issues were resolved and we are now testing and optimizing our MiQLabs. To support our sales efforts, I’m pleased to announce we have started an Early Access Program for key opinion leaders in veterinary and open-access markets. I expect we will be shipping our first unit(s) for this program by mid-Q4 of this year.”
In regards to pursuing SARS-CoV-2 (COVID-19) testing, the Company is working towards being the first company to put an open-access, fully automated, sample-to-answer system capable of testing for SARS-CoV-2 (Covid-19) through the FDA’s Emergency Use Authorization (EUA) process. For LexaGene, this process is substantially more difficult than for other companies that are simply looking to clear a PCR chemistry test through the FDA that can only be used in reference laboratories certified to perform high complexity testing. This is because LexaGene is putting forth not only a PCR chemistry test but also a fully automated sample-to-answer system that is simple enough that it could be used in near patient settings (e.g. not only in high complexity reference laboratories). Automating the test in near patient settings to reduce the time to result down from days to approximately 1 hour is a tremendous advantage for managing patient care and performing contact tracing.
LexaGene’s MiQLab is capable of purifying genetic material from a complex nasal or saliva sample, assembling and performing a multiplexed SARS-CoV-2 (Covid-19) PCR test, and reporting results in an automated fashion. Prior to starting the study, the FDA requires LexaGene to completely lock down all aspects of its technology, including the chemistry, microfluidic scripts, software, firmware, hardware (optical and heating elements), and the configuration of the sample preparation cartridge. There is a significant amount of optimization time required to lock down each component so they work seamlessly and robustly together such that the system reliably generates high quality data.
Furthermore, in the months since the FDA first established the EUA process, the agency has recognized many poor quality tests have entered the market and the FDA is actively working to identify and remove these tests from the market. Accordingly, the FDA has increasingly raised the bar for achieving EUA by putting in place more requirements to ensure the reliability and accuracy of testing procedures. In addition to the requirements for PCR chemistry-only kits, namely, sensitivity (limit-of-detection), specificity, and stability testing, LexaGene must also complete suites of tests on the system to demonstrate ship durability, electrical safety, system-to-system variability, as well as software validation and then finally perform an in-laboratory clinical study with patient samples. For these reasons, it is taking the Company longer to get ready to start the study than originally anticipated. Although LexaGene is making steady progress, due to the stringent nature of this process and its complexity, it is possible the Company will not start the study until the end of December. The Company is doing everything possible to bring in this timeline and will provide updates when warranted.
In preparation for the clinical study portion of the FDA study, LexaGene is pleased to announce that it has signed a Clinical Evaluation Study Agreement with the Dartmouth Hitchcock Medical Center, which will conduct the clinical portion of the study for the Company in their laboratory.
Until the proposed studies are completed and the FDA grants LexaGene’s MiQLab EUA for COVID-19 testing, LexaGene’s system and the associated tests cannot be used for clinical diagnostics. The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain COVID-19 (or SARS-CoV-2) at this time.
Lastly, LexaGene has revised the corporate website to reflect the Company’s maturity and readiness to introduce the MiQLab™ system to its target markets. The LexaGene website can be viewed at www.lexagene.com.
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On Behalf of the Board of Directors
Dr. Jack Regan
Chief Executive Officer & Director
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 one hour. 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.