LexaGene Intends to Pursue Full Panel Pathogen Testing through the FDA
November 24 2021 - 4:00PM
LexaGene Holdings, Inc., (OTCQB: LXXGF; TSX-V: LXG)
(“LexaGene” or the “Company”), a molecular diagnostics company
that has commercialized an instrument for automated multiplex PCR
testing, today announced it intends to pursue both 510k clearance
and CLIA-waiver from the FDA to utilize the full potential of the
MiQLab System™ for syndromic testing at the point of care.
Syndromic testing allows medical providers to simultaneously
test patient specimens for multiple pathogens that produce
overlapping signs and symptoms. MiQLab’s broad multiplexing
provides this capability and also allows for testing other
clinically important markers such as antimicrobial resistance
genes. Antimicrobial resistance is widely considered to be the next
global pandemic.1 Scientists estimate that drug resistant pathogens
will kill ~10 million people per year by the year 2050.2
Dr. Jack Regan, LexaGene’s Founder and CEO stated, “One of the
hardest challenges in medicine is to rapidly identify, at the
point-of-care, the exact cause of complex and difficult to treat
infections.3 We’ve developed the MiQLab to tackle this challenging
problem. It is capable of processing sample types that
traditionally inhibit PCR (e.g., urine and fecal samples) and
screens for up to 27 targets including drug resistance markers so
it can be used in the fight against superbugs. We believe the
MiQLab will be on the forefront of helping clinicians accurately
diagnose and treat their patients at the point of care so that a
pandemic caused by antimicrobial resistant pathogens can be
avoided. Similarly, syndromic panels like respiratory or
gastrointestinal panels will enable clinicians to more rapidly and
conveniently diagnose infectious diseases, enabling earlier
treatment and prevention.”
The Company has been steadily working to meet FDA requirements
for human clinical diagnostics. The progress we have made during
the pursuit of EUA for COVID-19 testing has brought the Company
closer toward meeting the more extensive requirements of the
traditional premarket review pathway, which will be required for
the Company to offer broad panel pathogen testing at the point of
care. The FDA recently provided industry-wide guidance4 and based
on this guidance and direct communications with the agency, the
Company has decided it will no longer pursue an EUA application for
COVID-19, but instead pursue 510k and CLIA-waiver for broad-panel
pathogen testing, thereby allowing the Company to focus on
providing the MiQLab technology for its intended use of syndromic
testing at the point of care.
LexaGene’s MiQLab system is unique in that it is a flow-through
PCR system. To LexaGene’s knowledge, the FDA has never received an
application for a flow-through PCR system for use in human clinical
diagnostics. Until the FDA grants LexaGene’s system authorization
for human clinical diagnostics, all work using LexaGene instruments
is classified as Research Use Only.
The Company continues to sell its technology into veterinary
hospitals, bio-pharmaceutical manufacturers, and other open-access
markets.
To learn more about LexaGene and the MiQLab System or subscribe
to company updates, visit www.lexagene.com, or follow us on Twitter
or LinkedIn.
On Behalf of the Board of DirectorsDr.
Jack ReganChief Executive Officer &
Chairman
Corporate & Media Contact:Gail
WinslowDirector, Marketinggwinslow@lexagene.com978.482.6237
Investors:ir@lexagene.com800.215.1824
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 two
hours. 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.nature.com/articles/s41591-020-01201-9#:~:text=Antibiotic%20resistance%20(AR)%20is%20widely,much%20less%20likely%20to%20succeed.2]
https://www.chemistryworld.com/features/the-antibiotic-countdown/3008544.article3]
https://www.cdc.gov/drugresistance/biggest-threats.html4]
https://www.fda.gov/media/135659/download
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