Using MiQLab system’s open-access capability for rapid test configuration
BEVERLY, Mass. USA – Feb 10, 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 announce that it has successfully configured a MiQLab™ system to detect mutant sequences unique to the United Kingdom (UK, B.1.1.7)1 and South African (SA, B.1.351)2 variants of SARS-CoV-2, the pathogen that causes COVID-19.
The UK variant, known to be more contagious and possibly deadlier, was first detected in the United States at the end of December and has now been identified in 33 states.3 Likewise, both the SA and Brazilian variants were first detected in the United States at the end of January, and several cases have now been reported in the United States, suggesting more widespread infections. The UK, SA, and Brazilian variants have now acquired mutations that may likely reduce the efficacy of approved vaccines and therapeutics.4,5
LexaGene’s MiQLab is designed for point-of-care use and for simultaneous screening of numerous respiratory pathogens, including COVID-19 strain identification. The system is open-access, which allows for new tests to be easily loaded onto the system. This is a unique feature that is not found in any other system designed for point-of-care use.
Dr. Jack Regan, LexaGene’s CEO and Founder states, “Just three weeks ago, we designed assays to detect the UK and SA variants to demonstrate proof-of-principle that these assays could be quickly ported onto the MiQLab. After just two full work days of having these reagents in-house, we verified our MiQLab could detect mutations associated with these variants. With proper FDA approvals, these tests could quickly be sent to MiQLabs operating at the point-of-care for faster detection, which would likely improve containment efforts for the spread of these new variants.”
Dr. Regan continues, “The optimism over the increasing availability of COVID-19 vaccines needs to be tempered with the worrisome potential that some of these new variants are not only more contagious, but also may render these vaccines less effective. Generally, getting a new vaccine authorized for use by FDA takes six or more months, so we really need to rely on better diagnostics to stop the spread of these new variants before they become more widespread and nearly impossible to contain. MiQLab’s open-access design allows the system to be quickly configured to detect new variants at the point-of-care. As such, our technology fills a critical testing gap we have in our defenses against these ever-changing pathogens.”
LexaGene is pursuing FDA EUA for COVID-19 testing using assays that are predicted to detect >99.9% of the strains circulating today based on published sequences, including the UK, SA, and Brazilian variants. At this time, LexaGene has no plans to incorporate the variant specific tests into the initial FDA studies for Emergency Use Authorization (EUA) for COVID-19 testing.
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.
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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.
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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.