LexaGene Starts FDA EUA Study for Point-of-Care COVID-19 Testing
December 30 2020 - 7:58AM
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 announce that it has started a series of studies
required by the FDA for Emergency Use Authorization (EUA) testing
for its COVID-19 assay in a point-of-care (POC) environment using
its fully automated MiQLab™ system.
Dr. Jack Regan, LexaGene’s CEO and Founder states, “I’m excited
we have progressed to the point where we have started our FDA
study. Our open-access technology is unlike any other on the market
today, as it could be configured quickly to detect new variants,
such as the recent UK variant1 (aka SARS-CoV-2 VUI 202012/01).
Since our system is capable of high multiplexing and is
microfluidic in nature, it is easy to add newly developed
Polymerase Chain Reaction (PCR) tests to detect variants that
are either poor matches to the vaccines or are resistant to any
developed therapies, which is critical to help get this pandemic
under control.”
The majority of tests authorized by the FDA for COVID-19 testing
are reagent-only chemistry tests that can only be used by trained
professionals in the 17,432 high complexity reference laboratories2
in the United States. These laboratories generally take at least a
day and sometimes as much as a week or more to return results,
which greatly complicates contact tracing. To speed up
time-to-result, the FDA has prioritized submissions for POC testing
solutions, where results can be generated on-site, soon after
collecting the sample.3 To help address this problem, LexaGene
anticipates submitting to the FDA for POC use status for its MiQLab
system so that the Company can provide COVID-19 tests to the
locations that need it most. There are 193,4744 locations certified
to run POC tests in the United States, making for a much larger
market opportunity than the high complexity laboratories alone.
For vendors submitting to the FDA EUA program, more studies are
required for authorization to sell into POC environments than are
required for selling into high complexity laboratories. This is
because POC PCR tests are automated, and the FDA must evaluate the
hardware, software, firmware, consumables, and chemistry associated
with the test. Furthermore, they must also evaluate whether the
technology is easy enough to use and has a low risk for erroneous
results. These added studies make submissions for POC testing
considerably more complex than submissions for simple reagent-only
chemistry tests that are used in high complexity reference
laboratories.
Dr. Regan concludes, “Obtaining FDA authorization for use at a
POC setting is a complicated and time-consuming process especially
for a novel technology such as LexaGene’s where FDA had no prior
opportunity to evaluate the MiQLab System. We are confident that we
can demonstrate to FDA the value of the MiQLab system and its
COVID-19 assay to combat this pandemic through POC testing. I look
forward to having deeper conversations with the FDA and presenting
our data to them.”
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.
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 &
Director
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.
1 https://www.ecdc.europa.eu/sites/default/files/documents/SARS-CoV-2-variant-multiple-spike-protein-mutations-United-Kingdom.pdf 2 https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/cert_type.pdf3 https://www.fda.gov/media/143737/download4 https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/cert_type.pdf
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