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.
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.cdc.gov/coronavirus/2019-ncov/transmission/variant-cases.html4
https://www.newscientist.com/article/2266429-uk-coronavirus-variant-gets-nastier-as-south-african-variant-spreads/5
https://www.cdc.gov/coronavirus/2019-ncov/transmission/variant.html
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