LexaGene Provides Corporate Update
March 11 2020 - 7:58AM
LexaGene Holdings, Inc. (OTCQB: LXXGF; TSX-V: LXG) (the
“Company”), a biotechnology company that develops genetic analyzers
for rapid pathogen detection and other molecular markers, provides
the following corporate update on the development of its commercial
technology and information on how the Company has responded to the
demand for its technology in view of the COVID-19 outbreak.
In response to the COVID-19 outbreak, the World Health
Organization has declared a ‘Public Health Emergency of
International Concern’ and the FDA has encouraged CLIA labs and IVD
manufacturers to submit applications for Emergency Use
Authorization (EUA) to help address the lack of quality diagnostics
to fight this disease. The FDA’s track record of granting EUA
during declared emergencies, such as the Ebola and Zika outbreaks,
provides management confidence that the Company’s decision to
pursue EUA is in the best interest of its shareholders, its future
customers and the patients they serve. Due to the
overwhelming interest in LexaGene’s rapid, on-site analyzer for the
detection of novel infectious diseases like COVID-19, LexaGene is
taking every measure to accelerate its FDA EUA submission.
LexaGene CEO and Founder, Dr. Jack Regan explains, “The rapid
spread of the novel disease COVID-19, with infections reported in
more than 90 countries and 37 U.S. states, highlights the failure
of existing diagnostics to contain a novel pathogen successfully.
To contribute to the solution for this outbreak and make us better
prepared for the next outbreak, LexaGene is now aggressively
pursuing the clinical diagnostics market. We also have the
personnel in place to remain on track to penetrate veterinary
diagnostics, food safety and other markets that require open-access
testing.”
Since the coronavirus outbreak, LexaGene has not only performed
in-house testing on its LX Analyzer using the CDC’s coronavirus
test, but the Company is also developing robust tests of its own
for SARS-CoV-2, the pathogen that causes COVID-19, as well as tests
for influenza A & B, human metapneumovirus, RSV, and human
adenovirus, as a start for a syndromic respiratory panel. LexaGene
is talking to several groups about placing one of its beta
instruments in the field for research coronavirus testing.
The Company plans to submit its own COVID-19 test to the FDA for
EUA to be run on the LX Analyzer.
Over the last several months, LexaGene has made significant
enhancements to the LX Analyzer, resulting in advanced performance
while reducing manufacturing costs for improved margins of the
commercial unit. The Company has begun manufacturing some of the
more complicated components of the instrument, such as its optical
module, and made several improvements to the analyzer’s design,
including:
- Design work for improved manufacturing and serviceability
- 30% reduction in size for an upgraded optical module
- 40% reduction in manufacturing costs for improved unit
pricing
- 15-fold improvement in sensitivity due to a new sample prep
cartridge (from initial data)
- A new fluidic configuration that reduces number of pumps and
valves by half
- Progress towards developing software to improve system
usability
Furthermore, the Company has recently contracted an
internationally renowned industrial design firm, Ximedica, to
accelerate its commercialization efforts. In addition, the
Company is in the final stages of hiring key positions in sales,
product marketing, quality, regulatory affairs, engineering, and
application support. The Company expects to announce some of these
hires in the near future.
LexaGene President and Co-founder Daryl Rebeck concludes,
“LexaGene’s progress has been tremendous. We’re doing each step of
development properly and we are on track to deliver a
next-generation pathogen detection system in Q3 of this year.”
About LexaGene Holdings Inc.LexaGene is a
biotechnology company that develops genetic analyzers for pathogen
detection and 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 LX Analyzer delivers excellent sensitivity,
specificity, and breadth of detection and can return results in
about 1 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.
Media Contacts Nicole Ridgedale Director of
Corporate Marketing, LexaGene800.215.1824 ext
206nridgedale@lexagene.com
Investor Relations Jay 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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