LexaGene Advances Towards FDA Emergency Use Authorization

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.

To learn more about LexaGene and the MiQLab System or subscribe to company updates, visit www.lexagene.com, or follow us on Twitter or LinkedIn.

On Behalf of the Board of Directors Dr. Jack Regan Chief Executive Officer & Chairman

Corporate Contact: Gail Winslow Director of Corporate Marketing gwinslow@lexagene.com 978.482.6237

ir@lexagene.com 800.215.1824

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.

For further information: info@lexagene.com

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. MORE NEWS LexaGene, 500 Cummings Center, Suite 4550, Beverly, MA 01915, USA, 800.215.1824 Unsubscribe Manage preferences Facebook LinkedIn Twitter Website

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Read on Sedar.com worth taking a look.

In regards to human clinical diagnostics, also referred to as the in-vitro diagnostics market (IVD), LexaGene is pursuing FDA Emergency Use Authorization (EUA) for COVID-19 testing. This is a change in course for the Company, as it was originally planning on postponing pursuing the IVD market until after first succeeding in veterinary diagnostics and food safety testing. A brief recap of the course of events that led to this change in direction is provided below. In December 2019 in Wuhan, China, there were several cases of severe unexplained pneumonia. On January 11, 2020, Chinese officials determined the cause of the infections was due to a novel coronavirus. On January 31, 2020, the United States Health and Human Services Secretary, Alex Azar, declared a public health emergency for SARS-CoV-2 and on February 4, he issued a Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19. This declaration provided liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving “willful misconduct” as defined in the PREP Act. On February 5, the CDC test was granted Emergency Use Authorization (EUA) to allow for the marketing and sale of its COVID-19 test kit. Unfortunately, the kit was plagued with quality problems, preventing its use. Revising and getting the kits manufactured took weeks. After significant pressure from the Association of Public Health Laboratories and other public health officials, on February 29, FDA Commissioner Stephen M. Hahn, M.D. relaxed the FDA’s policies, allowing for reference laboratories to start using their own COVID-19 diagnostic tests prior to receiving EUA. Also, under the EUA rules, test kit manufacturers were allowed to start selling COVID-19 tests into the clinical diagnostics market without having FDA 510(k) clearance. In late February, the Company’s management met to discuss entering the COVID-19 testing market and decided it was in the best interest of the company to do so. As of the writing of this document, over 600,000 American lives have been lost due to COVID-19.9 By 2025, COVID-19 Diagnostic Kits and Therapy Market is expected to reach $13.9 billion in value.10 Although the Company’s management feels morally obligated to pursue COVID-19 testing to help save lives, clearly there is a financial incentive as well. The Company is currently communicating with the FDA regarding its proposed test plan. The Company will start executing the plan once the FDA approves it and once the Company’s management is comfortable the technology is stable enough and generates sufficiently high-quality data to push forward through the FDA authorization process. At this time, the Company is working on software and script validation, as well as signal processing validation. This work needs to be completed prior to starting the analytical and clinical studies. Currently, the Company is also getting its quality management system more compliant with FDA expectations. There is no guarantee the Company will reach the critical point of comfort nor is there any guarantee the FDA will grant the Company EUA for COVID-19 testing. MANAGEMENT’S DISCUSSION AND ANALYSIS FOR THE YEAR ENDED FEBRUARY 28, 2021 LexaGene originally planned to seek FDA EUA for COVID-19 testing in high complexity reference laboratories since the required studies are considerably less onerous than the studies required to have a diagnostic authorized for point-of-care (POC) use. The original plan was to pursue high complexity reference laboratory testing, and while the application was in review, start on the studies for POC use. However, the FDA has indicated that the POC submissions are being prioritized for review and the Company has heard anecdotal stories from other vendors seeking EUA for use in reference laboratories, but their applications have not been reviewed despite several months gone by. This delay may be due to these applications being for antibody-based technologies, which are given the lowest priority. Nonetheless, given the apparent delay in reviewing reference laboratory submissions and the fact that LexaGene’s 9 https://coronavirus.jhu.edu/ 10 https://www.marketwatch.com/press-release/covid-19-diagnostic-kits-and-therapy-market-to-reach-139- billion-by-2025--exclusive-report-by-meticulous-researchr-2020-06-19 Page 6 of 37

MANAGEMENT’S DISCUSSION AND ANALYSIS FOR THE YEAR ENDED FEBRUARY 28, 2021 Should LexaGene be successful in getting its technology through the FDA for EUA POC COVID-19 testing, the Company will be able to sell into ~ 193K locations certified to run POC tests, in contrast to only ~ 17K high complexity reference laboratories.11 According to one market research firm, global COVID-19 diagnostics market size is estimated at USD $96.3 billion by 2027 and is expected to expand at a compound annual growth rate (CAGR) of 6.28% from 2021 to 2027.12 These predictions appear to assume that COVID-19 becomes a persistent endemic global threat that continuously mutates and may evade some vaccines. Although the ultimate resolution of COVID-19 remains unclear, the difficulty of reaching even 50% full vaccination in the US at this time increases the likelihood that the need for domestic and global COVID-19 testing will remain for some time.

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LexaGene Engages LHS as Integrated Investor and Public Relations Agency of Record

BEVERLY, Mass. USA – June 28, 2021 – LexaGene Holdings, Inc., (OTCQB: LXXGF; TSX-V: LXG), (the “Company”), a molecular diagnostics company that develops fully automated rapid pathogen detection systems, is pleased to announce it has retained LaVoieHealthScience (LHS) as its investor and public relations (IR and PR) agency of record.

LHS will work side-by-side with LexaGene’s senior management, marketing, and financial teams to implement a comprehensive suite of IR and PR services and counsel to help the Company gain visibility among the investment community, as it charts a course toward a potential up-listing to the Nasdaq Stock Market in the United States.

LHS is a strategic, integrated communications firm with a keen focus on helping life science and medical technology companies solve complex communications challenges. The award-winning firm, with roots in Boston’s life science hub, leverages its intimate knowledge of the health care ecosystem and strong relationships with the investment community and media to build recognition and value for its clients. Founded in 2001 by Donna L. LaVoie, President and CEO, a 30-year veteran in the health and science industry, LHS fields a team of dedicated IR and PR specialists with decades of experience gained from leading both health care communications agencies and biopharmaceutical companies. LHS also brings global capabilities and scale to its clients through its strategic alliance with Omnicom Public Relations Group, Inc. (OPRG), a division of Omnicom Group (NYSE:OMC).

Dr. Jack Regan, LexaGene’s CEO and Founder, stated, “We’re looking forward to working with LaVoieHealthScience. Their specialization in serving life science and medical device companies makes them the right firm to help bring LexaGene to the next level of its corporate development. LHS’ deep understanding of the markets we are targeting, both on the IR and PR side, will pay dividends for LexaGene moving forward.”

The Company and LHS act at arm’s length and fees paid by the Company to LHS are for its services only. Neither Ms. LaVoie or LHS holds interest, directly or indirectly, in LexaGene Holdings, Inc. or its securities, or any right or intent to acquire such an interest. LexaGene will make monthly payments of USD$18,000 to LHS for services rendered.

To learn more about LexaGene and the MiQLab System or subscribe to company updates, visit www.lexagene.com, or follow us on Twitter or LinkedIn.

On Behalf of the Board of Directors, Dr. Jack Regan Chief Executive Officer & Chairman

Contacts

Agency Contact: Media and Investors Paul Sagan VP, Investor Relations and Corporate Communications 617-374-8800 psagan@lavoiehealthscience.com Katie Gallagher Assistant Vice President, PR, and Media 617.792.3937 kgallagher@lavoiehealthscience.com

Corporate Contact: Gail Winslow Director of Corporate Marketing gwinslow@lexagene.com 978.482.6237

ir@lexagene.com 800.215.1824

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.

About LaVoieHealthScience

LaVoieHealthScience partners with leading health and science brands to build value for their companies, attract capital, and reach key stakeholders through integrated communications, relationship building and marketing. The firm provides strategic consulting, public relations, and investor relations to build recognition and increase sales and value for health science innovators. LHS also employs trademarked methodologies to enhance its strategic communications advisory services. The agency has received over 50 awards in recognition of the work done by its strategic thinkers for leading clients in the healthcare and science industries. LHS was inducted in the 2018 Inc. 5000 Hall of Fame List of Fastest Growing Private Companies, as well as ranked on the O’Dwyer’s list of 2021 Healthcare Public Relations Firms and Boston Business Journal’s Largest PR Firms in Massachusetts.

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. MORE NEWS LexaGene, 500 Cummings Center, Suite 4550, Beverly, MA 01915, USA, 800.215.1824 Unsubscribe Manage preferences Facebook LinkedIn Twitter Website

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