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 provide a general corporate update.
LexaGene aims to become the first company to sell a fully
automated, highly multiplexed, open-access, sample-to-answer system
for pathogen detection that is useful across multiple markets. The
Company’s primary markets are veterinary and human clinical
diagnostics, food safety, and markets that have custom genetic
testing needs, which it refers to as open-access markets.
LexaGene’s treasury currently stands at $11.3M USD ($14.9M CDN),
putting the Company in a strong position to support its development
goals for the next year and more.
Dr. Jack Regan, LexaGene’s Founder and CEO, states, “Our MiQLab™
pathogen detection system has 230 unique components. Over the
summer, the coronavirus pandemic caused some supply chain issues
for several key components that delayed the manufacturing,
optimization and testing of these systems. Just recently, these
supply chain issues were resolved and we are now testing and
optimizing our MiQLabs. To support our sales efforts, I’m pleased
to announce we have started an Early Access Program for key opinion
leaders in veterinary and open-access markets. I expect we will be
shipping our first unit(s) for this program by mid-Q4 of this
year.”
In regards to pursuing SARS-CoV-2 (COVID-19) testing, the
Company is working towards being the first company to put an
open-access, fully automated, sample-to-answer system capable of
testing for SARS-CoV-2 (Covid-19) through the FDA’s Emergency Use
Authorization (EUA) process. For LexaGene, this process is
substantially more difficult than for other companies that are
simply looking to clear a PCR chemistry test through the FDA that
can only be used in reference laboratories certified to perform
high complexity testing. This is because LexaGene is putting forth
not only a PCR chemistry test but also a fully automated
sample-to-answer system that is simple enough that it could be used
in near patient settings (e.g. not only in high complexity
reference laboratories). Automating the test in near patient
settings to reduce the time to result down from days to
approximately 1 hour is a tremendous advantage for managing patient
care and performing contact tracing.
LexaGene’s MiQLab is capable of purifying genetic material from
a complex nasal or saliva sample, assembling and performing a
multiplexed SARS-CoV-2 (Covid-19) PCR test, and reporting results
in an automated fashion. Prior to starting the study, the FDA
requires LexaGene to completely lock down all aspects of its
technology, including the chemistry, microfluidic scripts,
software, firmware, hardware (optical and heating elements), and
the configuration of the sample preparation cartridge. There is a
significant amount of optimization time required to lock down each
component so they work seamlessly and robustly together such that
the system reliably generates high quality data.
Furthermore, in the months since the FDA first established the
EUA process, the agency has recognized many poor quality tests have
entered the market and the FDA is actively working to identify and
remove these tests from the market. Accordingly, the FDA has
increasingly raised the bar for achieving EUA by putting in place
more requirements to ensure the reliability and accuracy of testing
procedures. In addition to the requirements for PCR
chemistry-only kits, namely, sensitivity (limit-of-detection),
specificity, and stability testing, LexaGene must also complete
suites of tests on the system to demonstrate ship durability,
electrical safety, system-to-system variability, as well as
software validation and then finally perform an in-laboratory
clinical study with patient samples. For these reasons, it is
taking the Company longer to get ready to start the study than
originally anticipated. Although LexaGene is making steady
progress, due to the stringent nature of this process and its
complexity, it is possible the Company will not start the study
until the end of December. The Company is doing everything possible
to bring in this timeline and will provide updates when
warranted.
In preparation for the clinical study portion of the FDA study,
LexaGene is pleased to announce that it has signed a Clinical
Evaluation Study Agreement with the Dartmouth Hitchcock Medical
Center, which will conduct the clinical portion of the study for
the Company in their laboratory.
Until the proposed studies are completed and the FDA grants
LexaGene’s MiQLab EUA for COVID-19 testing, LexaGene’s system and
the associated tests cannot be used for clinical diagnostics. The
Company is not making any express or implied claims that its
product has the ability to eliminate, cure or contain COVID-19 (or
SARS-CoV-2) at this time.
Lastly, LexaGene has revised the corporate website to reflect
the Company’s maturity and readiness to introduce the MiQLab™
system to its target markets. The LexaGene website can be viewed at
www.lexagene.com.
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 ContactsNicole 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.
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