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 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.
To be added to the LexaGene email list, please subscribe on the
Company website.
On Behalf of the Board of DirectorsDr.
Jack ReganChief 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.
For further information, please contact:
Media ContactNicole RidgedaleDirector of
Corporate Marketing, LexaGene800.215.1824 ext
206nridgedale@lexagene.com
Investor RelationsJay AdelaarVice President of
Capital Markets, LexaGene800.215.1824 ext
207jadelaar@lexagene.com
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.pdf2
https://www.eatthis.com/news-cdc-mutant-covid-south-africa/3
https://www.cnbc.com/2021/01/12/covid-mutations-all-the-major-strains-we-know-about.html4
https://www.cbsnews.com/news/covid-vaccine-new-strain-south-africa/?ftag=CNM-00-10aag7e5
https://www.livescience.com/amp/south-african-coronavirus-variant-antibody-resistant.html6
https://www.livescience.com/south-africa-variant-coronavirus-vaccines.html
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