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 corporate update from LexaGene’s CEO and
Founder Dr. Jack Regan.
Dear shareholders and other interested parties,
In late 2020, the Company crossed a major milestone by securing
sales in the contract drug and vaccine manufacturing market and in
veterinary medicine. Both sales were the result of successful
technology demonstrations.
As we scaled up manufacturing in late 2020 and early 2021, we
spent considerable efforts ensuring consistency in microfluidic
operations across MiQLab™ systems. Now that we have reached our
expectations for consistency, we are again ramping up
manufacturing. As of today, we have built 20 MiQLab systems and
have enough parts in-house or on order to build an additional 70
systems. Through a partnership with an FDA-compliant contract
manufacturer, we have the capacity to rapidly scale the
manufacturing of our consumables to meet demand.
We continue to invest resources in supporting the veterinary
diagnostics market, where we are designing and validating new
assays that will help veterinarians better detect disease-causing
pathogens and antimicrobial resistance markers to make
evidence-based treatment decisions.
I am happy to report that on April 14th, we will be hosting a
seminar for a select group of veterinarians, during which a key
opinion leader who is using our technology will present on
collected data. We anticipate providing further details via a press
release on the morning of the seminar.
The open-access market continues to be a focus for us,
specifically contract drug manufacturing organizations (CDMOs),
pharmaceutical companies, and cosmetic manufacturers. We are
aggressively developing new tests for these industries that will
further increase the value of our product as a quality control tool
to help keep vaccines, biologics, and consumer products safe.
Due to our increased confidence in the stability of our
manufacturing process and very positive interactions with key
opinion leaders in veterinary medicine and CDMOs, over the next six
weeks, we anticipate hiring 4 – 6 sales representatives to improve
our coverage across the United States. In support of our sales
staff, our marketing team continues to generate collateral needed
to help the sales team educate prospective customers. A video on
the MiQLab user workflow was recently completed and can be viewed
on the company website at
https://lexagene.com/miqlab-training-video/.
Over the last three months, we have made substantial progress on
FDA requirements for software and hardware testing which are
pre-requisites to complete the COVID-19 EUA application.
On the biology side, our preliminary limit-of-detection (LoD)
tests for SARS-CoV-2 suggest the MiQLab sensitivity is competitive
with the best point-of-care molecular systems on the market today.
We plan to continue the additional work needed for the COVID-19 EUA
application as soon as we complete the validation work necessary
for the MiQLab’s software, signal processing algorithm, and
microfluidic scripts. The FDA study involves multiple additional
analytical studies, which we need to complete prior to starting the
point-of-care clinical study. At this time, it is difficult to
predict the length of time we will need to complete this work.
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.
Thank you for your continued support.
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 &
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 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.
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