LexaGene Completes Analytical Studies for FDA EUA of COVID-19 Testing
October 25 2021 - 7:45AM
LexaGene Holdings, Inc., (OTCQB: LXXGF; TSX-V: LXG)
(“LexaGene” or the “Company”), a molecular diagnostics company
that has commercialized an instrument for automated multiplex PCR
testing for veterinary diagnostics and biopharmaceutical
manufacturing, today announced it has completed its analytical
studies required by the FDA for an Emergency Use Authorization
(EUA) application for COVID-19 diagnostics.
LexaGene is in the process of completing the
necessary work to have the FDA rule on authorizing the MiQLab™ for
COVID-19 testing. The FDA is expected to classify the MiQLab as a
class II medical device. As such, the process of preparing its
point-of-care (POC) fully-automated PCR system, which is comprised
of hardware, firmware, software, and chemistry, for evaluation by
the FDA, is considerably more complex than if it were simply
submitting only a COVID-19 PCR test chemistry for FDA
authorization.
Dr. Jack Regan, LexaGene’s CEO and Founder
stated, “Successfully completing these studies is a big step for
LexaGene, as these data could only be collected after we have
sufficiently met a number of requirements for system/software
verification, electrical safety testing, manufacturing process
qualification, quality control, and the associated documentation.
It is our belief that the quality of our data will meet FDA
expectations. Our next step is to have a third party conduct a
COVID-19 clinical evaluation using the MiQLab System at both a POC
testing facility and a clinical laboratory, and then the analytical
and clinical data will be compiled and submitted to the FDA for
authorization.”
The following analytical studies were completed
using multiple MiQLab Systems:
- External Quality Control Validation
- Analytical Sensitivity: Limit of Detection (LoD)
- Analytical Specificity: Cross-Reactivity
- Endogenous Interference Substances Studies
- Carry-over/Cross-Contamination Study
- Sample Stability
Dr. Regan continued, “This milestone should be
viewed as having much broader implications than COVID-19 testing
only. Our goal is to get our technology through the FDA so that we
can leverage the system’s high-quality sample preparation followed
by broad-multiplex PCR analysis, which is a combination of features
that many currently authorized COVID-19 only testing devices do not
have. These features make the MiQLab ideally suited for syndromic
testing of complex diseases that can be caused by 10 or more
pathogens, such as respiratory diseases (e.g., COVID-19, influenza
A & B, RSV, adenovirus, metapneumovirus, etc.),
gastro-intestinal diseases, urinary tract diseases, and skin and
soft tissue diseases. Preparing our technology to be able to
successfully collect the analytical COVID-19 data is arguably the
hardest step in the EUA process. If we are successful in being
authorized for COVID-19 testing, we will follow this work with
studies to support 510(k) applications for complex diseases in
human clinical medicine.”
LexaGene’s MiQLab system is unique in that it is
a flow-through PCR system. To LexaGene’s knowledge, the FDA has
never received an application for a flow-through PCR system for use
in human clinical diagnostics. It is possible the FDA will require
additional studies prior to passing final judgement. Once the
required studies are complete, there is no guarantee the FDA will
deem the data to be satisfactory for authorization of the system
for human clinical diagnostics. Prior to the FDA’s ruling, all data
and communications with the FDA are deemed private. Until the FDA
grants LexaGene’s system EUA for COVID-19 testing, all work using
LexaGene instruments is classified as Research Use Only and cannot
be used for human clinical diagnostics.
An interview with Dr. Regan can be viewed
HERE.
To learn more about LexaGene and the MiQLab
System or subscribe to company updates, visit www.lexagene.com, or
follow us on Twitter or LinkedIn.
On Behalf of the Board of
DirectorsDr. Jack ReganChief
Executive Officer & Chairman
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 two hours. 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.
The TSX Venture Exchange Inc. has in no way
passed upon the merits of the proposed transaction and has neither
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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
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The company disclaims any intention or obligation, except to the
extent required by law, to update or revise any forward-looking
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Corporate & Media Contact:
Gail Winslow
Director of Marketing
gwinslow@lexagene.com
978.482.6237
ir@lexagene.com
800.215.1824
Investors:
Sharon Choe
Vice President
LaVoieHealthScience
schoe@lavoiehealthscience.com
(857) 241-7393
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