LexaGene Advances Towards FDA Emergency Use Authorization
July 02 2021 - 7:45AM
LexaGene Holdings, Inc., (OTCQB: LXXGF; TSX-V: LXG) (the
“
Company”), a molecular diagnostics company that
develops fully automated rapid pathogen detection systems, today
announced it continues to systematically advance the MiQLab™ System
to meet the Food and Drug Administration (FDA) criteria for
Emergency Use Authorization (EUA). The MiQLab System is a first of
its kind, point of care diagnostic testing technology.
The FDA EUA process requires novel diagnostic devices to undergo
a substantial amount of complex design control and testing. All
functions for critical system operation must be validated and
submitted as part of the process.
Dr. Jack Regan, LexaGene’s Founder and CEO, stated, “The MiQLab
systems we’ve sold into veterinary diagnostics and the biologics
manufacturing market are in the field and working as designed. Part
of our strategy is to use these systems in real-world settings,
processing complex samples, to ensure our technology is ready to
pass the stringent FDA requirements. The intent of the FDA
requirements is to ensure vendors take the necessary steps to get
the highest quality product possible out of their specific
technology. Over the last few months, LexaGene has made great
progress and completed many of these requirements. Namely, we have
passed electrical safety testing, passed ship testing, finalized
our master mix and carrier fluid formulation, finalized our test
assays and their configuration, finalized our internal
amplification control and internal process control, and completed
our user manual to a state acceptable for an EUA submission.”
Steve Armstrong, LexaGene’s Chief Operational Officer, stated,
“We are making great strides on the remaining requirements. Namely,
we are in the process of verifying our longer reagent shelf-life
(i.e., stability of our on-board reagents). We are also working on
completing system software validation, including error handling.
We’ve also been working on verifying an automated microfluidic
scheduler as well as further refining our standard scripts for
automated sample preparation and assay assembly. We continue work
required to verify our thermal and optical parameters for optimal
PCR amplification. Likewise, we are working on validating our
signal processing algorithm and ensuring our reports are
consistently accurate. Finally, we are making process improvements
so we can scale manufacturing. Once the Company fully completes
these necessary steps, the MiQLab will be fully optimized and ready
for analytical and point-of-care clinical validation for EUA
submission.”
Mr. Armstrong continued, “Coronavirus continues to present a
real danger in the United States and internationally. The MiQLab is
perfectly positioned to address this large and critically important
market. LexaGene is eager to complete the FDA requirements as
quickly as possible. To date, no novel fully integrated
sample-to-answer, multiplex technology has made it through the EUA
application process. LexaGene’s MiQLab may be the first. For our
EUA application, we are taking a very methodical approach to this
work. We look forward to the day when the MiQLab is being used as a
valuable asset in the fight against COVID-19 and its deadly
variants.”
The Company will periodically provide progress updates on our
FDA EUA work.
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. Also, despite the optimism
management has regarding the potential of getting the MiQLab
approved for EUA by the FDA for COVID-19 testing in humans, there
is no guarantee the FDA will grant such approval.
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
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.
Corporate Contact:
Gail Winslow
Director of Corporate Marketing
gwinslow@lexagene.com
978.482.6237
ir@lexagene.com
800.215.1824
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