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 that it has initiated a program that uses the rapid configurability of the MiQLab™ system to investigate novel variants of SARS-CoV-2, the pathogen that causes COVID-19.
SARS-CoV-2 is a pathogen that mutates quickly. New variants were recently identified in the United Kingdom (B.1.1.7)1 and South Africa (B.1.351).2 Both new strains appear to be about 70% more contagious, making containment that much more challenging.3 Also, some scientists are concerned that the South African strain may not be a good match for developed vaccines and antibody-based therapeutics.4,5,6
Dr. Jack Regan, LexaGene’s CEO and Founder states, “It is hard to estimate the impact of a new variant that can re-infect those who have already been infected or vaccinated. It is critical that we have the capability to not only detect whether the patient is COVID-19 positive, but also whether they are, in fact, infected with a new variant. We need to be able to more quickly and accurately identify new strains at the point-of-care, as this potentially could have helped better contain SARS-CoV-2 at the start of the outbreak.”
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 and South African variants. Given the suspected higher rate of transmissibility of these variants, it is of clinical importance to be able to distinguish these new variants from the original strain. LexaGene’s MiQLab can be easily configured to run tests for both coronavirus detection and strain identification as it is capable of screening for up to 27 genetic targets at once.
Dr. Regan continues, “We founded LexaGene to fill a critical technology gap in our defenses against new pathogens. LexaGene’s MiQLab is designed to be a point-of-care system that is open-access in nature. Once a pathogen emerges or mutates, the MiQLab system is designed to quickly onboard new tests to detect a desired target, which would speed up timelines for point-of-care testing. Detecting these variants quickly inside hospitals, clinics, and other testing locations maximizes the chances of successfully containing these new threats.”
To date, there is no FDA approved device that is designed for point-of-care usage and is open-access.
LexaGene has designed and ordered components for tests to distinguish the UK and South African strains from the traditional coronavirus strain and will confirm these work as expected on the MiQLab system.
At this time, LexaGene has no plans to incorporate these new tests into the FDA studies for Emergency Use Authorization (EUA) for COVID-19 testing, which began late last month.
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.