LexaGene Places a Pre-Commercial Instrument for COVID-19 Testing in a Major Hospital Laboratory
May 28 2020 - 7:55AM
LexaGene Holdings, Inc. (TSX-V: LXG; OTCQB: LXXGF) (the
“
Company”), a biotechnology company that develops
genetic analyzers for rapid pathogen detection and other molecular
markers, is pleased to announce the placing of a pre-commercial
instrument that tests for COVID-19 and other respiratory pathogens
at the Dartmouth-Hitchcock Medical Center (DHMC) in their
Laboratory for Clinical Genomics and Advanced Technology (CGAT) in
Hanover, New Hampshire.
Dr. Gregory J. Tsongalis, PhD, HCLD, CC, Professor and Vice
Chair for Research Director at CGAT comments, “Our standard test
for SARS-CoV-2, the pathogen that causes COVID-19, takes about 7.5
hours. Given the highly contagious nature of this virus, this
is a long time to wait. We want the ability to get results
much faster and to be able to screen for more pathogens at once
since respiratory symptoms can be caused by numerous other
viruses.”
Dr. Jack Regan, LexaGene’s Founder and CEO, states, “We are
excited to be able to contribute to the fight against COVID-19 and
illustrate our applications in the human clinical space.
Unlike many of the near-patient testing solutions used today that
only look for COVID-19 and have a significant false negative rate,
the instrument we have placed at Dartmouth-Hitchcock screens for
many pathogens at once, namely COVID-19, influenza, RSV,
adenovirus, metapneumovirus, and seasonal coronavirus, and it
performs gold-standard chemistry for exceptional data
quality. Our breadth of detection allows users of our
technology to generate informative data for the vast majority of
people with respiratory symptoms. This is particularly
important as healthcare providers are increasingly questioning
negative results from COVID-19 only tests, wondering if the test
result is a false negative or the person is sick from another
pathogen.”
The Company is also pleased to report that we have submitted our
plan to the FDA for Emergency Use Authorization (EUA) for COVID-19
testing and anticipates completing the described studies in the
near future. Until these studies are completed and 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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