LexaGene Introduces its Commercial Product MiQLab™
Automated, genetic analyzer designed for rapid, point-of-need testing
BEVERLY, Mass. USA – July 13, 2020 – LexaGene Holdings, Inc., (TSX-V: LXG; OTCQB: LXXGF) (the “Company”), a molecular diagnostics company that develops genetic analyzers for rapid pathogen detection, is pleased to announce the name and first look of the Company’s flagship product, called MiQLab™, which can be seen on the Company’s website, and is being manufactured for an anticipated commercial launch prior to the end of September 2020.
As announced, LexaGene will be hosting a webinar to provide additional information as well as a general corporate overview at 2 PM EST on July 14, 2020. All are invited to register for the webinar at this link: https://event.webcasts.com/starthere.jsp?ei=1294081&tp_key=b029bb1560.
Dr. Jack Regan, LexaGene’s CEO and Founder, states, “We started this company with a vision to create a technology that the world needs, particularly during these difficult times as we struggle to contain the spread of COVID-19. We have finished incorporating the feedback from beta testing and have begun manufacturing our commercial instrument, the MiQLab genetic analyzer. It is extremely gratifying to be so close to the start of selling this much-needed technology.”
MiQLab is a fully automated genetic analyzer that is designed to deliver reference-quality data at the point-of-need. MiQLab’s technology screens samples for up to 27 different targets at once—looking for pathogens and/or antimicrobial resistance factors—and returns results in approximately one hour. It is designed to be operated at the site of sample collection to avoid the delay associated with shipping and manually processing samples. This technology is designed for use in multiple markets, including human and veterinary diagnostics, as well as food safety testing ($12.9B1, $2.2B2, and $23.4B3 markets, respectively).
MiQLab is open-access, which allows users to customize their tests easily. We have done extensive research and found no commercially available point-of-need instruments that allow for easy assembly and performance of highly multiplexed tests. As such, we’ve concluded no comparable technology exists on the market today, providing LexaGene a unique opportunity to target this market, which is valued at $20B4-7. Scientists who have custom testing needs make up the open-access market, and they currently spend hours a day to manually perform PCR testing. These same individuals will now have the opportunity to save hours a day by having MiQLab automate the processing of their own tests.
Dr. Regan continues, “We are not only manufacturing the device, but also the associated consumables for our razor blade business model. Our consumables include the single use disposable cartridge for sample preparation as well as the PCR test chemistry, which MiQLab automates. At volume manufacturing, we expect the costs for our consumables to be substantially lower than competing technologies, which will allow us to maintain healthy profit margins even when selling into cost sensitive markets.”
To start, the Company anticipates offering three sets of chemistries, namely a COVID-19 test ($5.2B market in 20208), a bacterial and antimicrobial panel for veterinary diagnostics that will screen for 8 different pathogens (E. coli, Proteus, Klebsiella, Enterobacter, Pseudomonas, Staphylococcus, Streptococcus and Enterococcus) and 12 antibiotic resistance factors including methicillin and vancomycin resistance, and an open-access panel to facilitate customized genetic testing.
LexaGene has submitted a preliminary plan for COVID-19 testing to the FDA and is still in conversations with the agency regarding the proposed studies for this novel technology. As is standard practice, until the FDA grants LexaGene’s instrument EUA for COVID-19 testing, all work using LexaGene instruments is classified as Research Use Only and cannot be used for human 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-2 Coronavirus) at this time.
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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 genetic analyzers for pathogen detection and 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™ analyzer 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.
For further information, please contact:
Director of Corporate Marketing, LexaGene
800.215.1824 ext 206
Vice President of Capital Markets, LexaGene
800.215.1824 ext 207
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.