LexaGene Status Update on COVID-19 Testing at a Major Hospital Laboratory

LexaGene Provides Status Update on COVID-19 Testing at a Major Hospital Laboratory

BEVERLY, Mass. USA – June 18, 2020 –  LexaGene Holdings, Inc., (TSX-V: LXG; OTCQB: LXXGF) (the “Company”), a biotechnology company that develops genetic analyzers for rapid pathogen detection and other molecular markers, is pleased to provide a status update on the previously announced placement of its pre-commercial LX Analyzer.

The instrument the Company placed in a major US hospital laboratory was configured to screen for COVID-19 and seven other respiratory pathogens. LexaGene’s technology performs highly multiplex RT-PCR, which is a gold-standard chemistry that provides exceptional sensitivity and specificity. LexaGene has automated the entire workflow in an instrument designed to be placed at the point-of-need. It takes less than 1 minute of hands-on time to initiate sample processing for walk-away testing.

Daryl Rebeck, LexaGene’s President and Co-Founder, states, “These have been very exciting times for LexaGene where the device has been put into the field for testing of a novel pathogen. Developing a tool for pandemic prevention is one of the main visions that Jack and I had when founding the Company four years ago. The goal was always to provide testing that can be rapidly configured in an outbreak for early detection and containment, which we can accomplish with our open-access platform to help avoid delays and supply issues associated with all the closed access testing systems in the industry. As a foremost expert in biothreat and infectious diseases, Jack’s deep knowledge makes us very well suited to provide a solution to this ongoing pandemic that has created such a significant worldwide burden.”

Dr. Jack Regan, LexaGene’s Founder and CEO, states, “From the samples tested to date, we have detected numerous positive COVID-19 samples as well as negative samples which are equally important. In contrast to many technologies that only provide a ‘yes’ or ‘no’ answer as to whether the virus was detected, LexaGene’s technology provides quantitative data on how much virus is detected. By quantifying the amount of virus present, we can help clinicians determine if a patient is possibly early in the infection cycle, late in the infection cycle, or if their immune system successfully contained the growth of the virus. In the hospital study, we have detected COVID-19 positive samples that are more than 25,000-fold different in the amount of detected virus. Quickly identifying individuals with such high viral loads is especially important for disease containment.”

Regarding the Company’s FDA plans, LexaGene has recently received comments back on its submitted plan for Emergency Use Authorization (EUA) for COVID-19 testing. Since submitting the application, the FDA has updated its template for manufacturers, changing some requirements. The Company has amended its plan and is now awaiting further communication from the FDA, which it anticipates soon. Until proposed studies are completed, and the FDA grants LexaGene’s instrument EUA for COVID-19 testing, all work using LexaGene instruments is classified as “Research Use Only” which is standard for the industry. 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 biotechnology 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 LX Analyzer delivers excellent sensitivity, specificity, and breadth of detection and can return results in about 1 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.

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