BEVERLY, Mass. USA – April 1, 2021 – 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 corporate update from LexaGene’s CEO and Founder Dr. Jack Regan.
Dear shareholders and other interested parties,
In late 2020, the Company crossed a major milestone by securing sales in the contract drug and vaccine manufacturing market and in veterinary medicine. Both sales were the result of successful technology demonstrations.
As we scaled up manufacturing in late 2020 and early 2021, we spent considerable efforts ensuring consistency in microfluidic operations across MiQLab™ systems. Now that we have reached our expectations for consistency, we are again ramping up manufacturing. As of today, we have built 20 MiQLab systems and have enough parts in-house or on order to build an additional 70 systems. Through a partnership with an FDA-compliant contract manufacturer, we have the capacity to rapidly scale the manufacturing of our consumables to meet demand.
We continue to invest resources in supporting the veterinary diagnostics market, where we are designing and validating new assays that will help veterinarians better detect disease-causing pathogens and antimicrobial resistance markers to make evidence-based treatment decisions.
I am happy to report that on April 14th, we will be hosting a seminar for a select group of veterinarians, during which a key opinion leader who is using our technology will present on collected data. We anticipate providing further details via a press release on the morning of the seminar.
The open-access market continues to be a focus for us, specifically contract drug manufacturing organizations (CDMOs), pharmaceutical companies, and cosmetic manufacturers. We are aggressively developing new tests for these industries that will further increase the value of our product as a quality control tool to help keep vaccines, biologics, and consumer products safe.
Due to our increased confidence in the stability of our manufacturing process and very positive interactions with key opinion leaders in veterinary medicine and CDMOs, over the next six weeks, we anticipate hiring 4 – 6 sales representatives to improve our coverage across the United States. In support of our sales staff, our marketing team continues to generate collateral needed to help the sales team educate prospective customers. A video on the MiQLab user workflow was recently completed and can be viewed on the company website at https://lexagene.com/miqlab-training-video/.
Over the last three months, we have made substantial progress on FDA requirements for software and hardware testing which are pre-requisites to complete the COVID-19 EUA application.
On the biology side, our preliminary limit-of-detection (LoD) tests for SARS-CoV-2 suggest the MiQLab sensitivity is competitive with the best point-of-care molecular systems on the market today. We plan to continue the additional work needed for the COVID-19 EUA application as soon as we complete the validation work necessary for the MiQLab’s software, signal processing algorithm, and microfluidic scripts. The FDA study involves multiple additional analytical studies, which we need to complete prior to starting the point-of-care clinical study. At this time, it is difficult to predict the length of time we will need to complete this work.
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. To date, there is no FDA-approved device that is designed for point-of-care usage and is open-access.
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.
Thank you for your continued support.
To be added to the LexaGene email list, please subscribe on the Company website.
On Behalf of the Board of Directors
Dr. Jack Regan
Chief Executive Officer & Chairman
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.