LexaGene Provides Update on Commercializing its Automated Pathogen Detection System
June 01 2020 - 8:49AM
LexaGene Holdings, Inc., (TSX-V: LXG; OTCQB: LXXGF) (the
“
Company”) a biotechnology company that develops
genetic analyzers for rapid pathogen detection is pleased to
provide the following update on the Company’s development plans of
its flagship pathogen detection platform for the human clinical,
veterinary diagnostics, and food safety sectors.
As previously announced, LexaGene has recently placed a
pre-commercial unit of its LX Analyzer in a major US hospital
laboratory for the testing of COVID-19 and has submitted its plan
to the FDA for Emergency Use Authorization (EUA). The Company also
recently gave an interview to expand on this news.
Dr. Jack Regan, CEO and Founder of LexaGene, states, “The
analyzer’s multiplex testing capability is an important part of
future testing needs, especially if the anticipated second wave of
COVID-19 testing in the fall occurs with the added burden of a new
flu season. The LX Analyzer is capable of testing for COVID-19, as
well as flu and other common respiratory pathogens such as
adenovirus and RSV at the point-of-need in clinics, hospitals, or
elsewhere in the field. Hospitals have told us what they need, and
we are working with partners on the research of this deadly virus
with the hope of being the testing provider they choose. We are
pleased so far with the results of our current placement.”
To support ramping up of final improvements to the
pre-commercial system and manufacturing process, LexaGene has
recently hired two additional members to the product development
team in the areas of software and systems engineering. The Company
also plans to hire sales staff in the summer in advance of the
commercial launch in the fall.
LexaGene is in the final stages of selecting a contract
manufacturer to assist beyond the Company’s in-house manufacturing
capabilities in scaling up production of its analyzers in the fall
to help meet the demand of testing needs in various markets.
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.
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.
On Behalf of the Board of Directors Signed "Dr. Jack
Regan" Dr. Jack Regan, Chairman of the Board of Directors &
Chief Executive Officer
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.
For further information, please contact:
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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