LexaGene Provides Status Update on COVID-19 Testing at a Major Hospital Laboratory
June 18 2020 - 7:58AM
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 provide a status update on the previously
announced placement of its pre-commercial LX Analyzer.
The instrument the Company placed in a major US hospital
laboratory was configured to screen for COVID-19 and seven other
respiratory pathogens. LexaGene’s technology performs highly
multiplex RT-PCR, which is a gold-standard chemistry that provides
exceptional sensitivity and specificity. LexaGene has automated the
entire workflow in an instrument designed to be placed at the
point-of-need. It takes less than 1 minute of hands-on time to
initiate sample processing for walk-away testing.
Daryl Rebeck, LexaGene’s President and Co-Founder, states,
“These have been very exciting times for LexaGene where the device
has been put into the field for testing of a novel pathogen.
Developing a tool for pandemic prevention is one of the main
visions that Jack and I had when founding the Company four years
ago. The goal was always to provide testing that can be rapidly
configured in an outbreak for early detection and containment,
which we can accomplish with our open-access platform to help avoid
delays and supply issues associated with all the closed access
testing systems in the industry. As a foremost expert in biothreat
and infectious diseases, Jack’s deep knowledge makes us very well
suited to provide a solution to this ongoing pandemic that has
created such a significant worldwide burden.”
Dr. Jack Regan, LexaGene’s Founder and CEO, states, “From the
samples tested to date, we have detected numerous positive COVID-19
samples as well as negative samples which are equally important. In
contrast to many technologies that only provide a ‘yes’ or ‘no’
answer as to whether the virus was detected, LexaGene’s technology
provides quantitative data on how much virus is detected. By
quantifying the amount of virus present, we can help clinicians
determine if a patient is possibly early in the infection cycle,
late in the infection cycle, or if their immune system successfully
contained the growth of the virus. In the hospital study, we have
detected COVID-19 positive samples that are more than 25,000-fold
different in the amount of detected virus. Quickly identifying
individuals with such high viral loads is especially important for
disease containment.”
Regarding the Company’s FDA plans, LexaGene has recently
received comments back on its submitted plan for Emergency Use
Authorization (EUA) for COVID-19 testing. Since submitting the
application, the FDA has updated its template for manufacturers,
changing some requirements. The Company has amended its plan and is
now awaiting further communication from the FDA, which it
anticipates soon. Until proposed 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”
which is standard for the industry. 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-2 Coronavirus) at this
time.
To be added to the LexaGene email list, please subscribe on the
Company website.
On Behalf of the Board of Directors
Dr. Jack ReganChief Executive Officer
& Director
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.
Lexagene (TSXV:LXG)
Historical Stock Chart
From Jun 2024 to Jul 2024
Lexagene (TSXV:LXG)
Historical Stock Chart
From Jul 2023 to Jul 2024