LexaGene Starts FDA EUA Study

LexaGene Starts FDA EUA Study for Point-of-Care COVID-19 Testing

BEVERLY, Mass. USA – Dec 30, 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 announce that it has started a series of studies required by the FDA for Emergency Use Authorization (EUA) testing for its COVID-19 assay in a point-of-care (POC) environment using its fully automated MiQLab™ system.

Dr. Jack Regan, LexaGene’s CEO and Founder states, “I’m excited we have progressed to the point where we have started our FDA study. Our open-access technology is unlike any other on the market today, as it could be configured quickly to detect new variants, such as the recent UK variant[1] (aka SARS-CoV-2 VUI 202012/01). Since our system is capable of high multiplexing and is microfluidic in nature, it is easy to add newly developed Polymerase Chain Reaction (PCR) tests to detect variants that are either poor matches to the vaccines or are resistant to any developed therapies, which is critical to help get this pandemic under control.”

The majority of tests authorized by the FDA for COVID-19 testing are reagent-only chemistry tests that can only be used by trained professionals in the 17,432 high complexity reference laboratories[2] in the United States. These laboratories generally take at least a day and sometimes as much as a week or more to return results, which greatly complicates contact tracing. To speed up time-to-result, the FDA has prioritized submissions for POC testing solutions, where results can be generated on-site, soon after collecting the sample.[3] To help address this problem, LexaGene anticipates submitting to the FDA for POC use status for its MiQLab system so that the Company can provide COVID-19 tests to the locations that need it most. There are 193,474[4] locations certified to run POC tests in the United States, making for a much larger market opportunity than the high complexity laboratories alone.

For vendors submitting to the FDA EUA program, more studies are required for authorization to sell into POC environments than are required for selling into high complexity laboratories. This is because POC PCR tests are automated, and the FDA must evaluate the hardware, software, firmware, consumables, and chemistry associated with the test. Furthermore, they must also evaluate whether the technology is easy enough to use and has a low risk for erroneous results. These added studies make submissions for POC testing considerably more complex than submissions for simple reagent-only chemistry tests that are used in high complexity reference laboratories.

Dr. Regan concludes, “Obtaining FDA authorization for use at a POC setting is a complicated and time-consuming process especially for a novel technology such as LexaGene’s where FDA had no prior opportunity to evaluate the MiQLab System. We are confident that we can demonstrate to FDA the value of the MiQLab system and its COVID-19 assay to combat this pandemic through POC testing. I look forward to having deeper conversations with the FDA and presenting our data to them.”

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 the 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 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.


[1] https://www.ecdc.europa.eu/sites/default/files/documents/SARS-CoV-2-variant-multiple-spike-protein-mutations-United-Kingdom.pdf

[2] https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/cert_type.pdf

[3] https://www.fda.gov/media/143737/download

[4] https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/cert_type.pdf

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