LexaGene Holdings, Inc., (OTCQB: LXXGF; TSX-V: LXG)
(“LexaGene” or the “Company”), a molecular diagnostics company that
develops fully automated rapid pathogen detection systems, today
announced it has successfully utilized its MiQLab™
System (“MiQLab”) to detect the presence of mycoplasmas, a
group of common microbial contaminants responsible for substantial
losses in both time and money for biopharmaceutical manufacturers.
Dr. Jack Regan, LexaGene’s CEO and Founder
stated, “We are increasingly harnessing the power of our MiQLab to
drastically shorten the time-to-result for microbial
biopharmaceutical contamination detection. Last month, LexaGene
announced it could detect Cutibacterium acnes 36 to 168 times
faster than conventional methods. Through our research and
development efforts, MiQLab technology can now readily detect
mycoplasmas, a group of pervasive and highly problematic
contaminants. We expect the time benefit of MiQLab Mycoplasma Test
to be up to 300 times faster than conventional methods. These
findings are significant for biopharmaceutical manufacturers and
other life science companies. We are aggressively developing more
tests for this industry so we can provide them a complete solution
for their contamination testing needs.”
A brief interview with Dr. Regan may be viewed
here.
About Bioprocessing and
MycoplasmasBioprocessing can be broadly defined as the
utilization of living organisms to manufacture biological-based
products.1 The bioprocessing workflow can be broken down into three
stages: upstream, harvest, and downstream.2 The upstream aspect
involves setting up culture conditions to maximize cellular growth.
Once cells reach a high enough concentration, they are harvested so
that biological product can be extracted, isolated, concentrated,
and purified to make the final product.
Mycoplasmas are thought to contaminate 15 to 80
percent of cell cultures worldwide.3 Common methods for mycoplasma
detection are extremely slow, taking approximately 28 days for
definitive results.4 Routine microbial contaminant testing during
bioprocessing is imperative to maintain control over product yield,
quality, safety, efficacy, and to correctly identify microbial
contamination. Reducing the time to result is crucial to allow
companies to make swift and precise decisions. There are
significant financial implications for a mycoplasma contamination
event, where examination and decontamination procedures, corrective
actions, product shortages, and damages to the manufacturers brand
can lead to millions of dollars spent per incident.5
LexaGene’s MiQLab Mycoplasma Test and
Test ResultsLexaGene’s MiQLab Mycoplasma Test is designed
to detect the most relevant mycoplasma species for microbial
contamination in bioprocessing, specifically Mycoplasma arginini,
Mycoplasma orale, Mycoplasma hyorhinis, Mycoplasma fermentans, as
well as Acholeplasma laidlawii.6
To validate the ability of the MiQLab Mycoplasma
Test to accurately detect mycoplasmas, while dramatically reducing
time to result, mycoplasma strains (M. arginini, M. cynos, and A.
laidlawii) were spiked into a selective medium and incubated under
appropriate growth conditions where a color change of the medium
represented presumptive detection of microbial growth. These
samples were harvested and processed on a MiQLab, which
successfully detected all the samples with 100 percent accuracy.
Future studies will determine the limit of detection for the
Mycoplasma Test.
To test the specificity of the Mycoplasma Test,
very high concentrations of common contaminants (Escherichia coli,
Staphylococcus aureus, Streptococcus agalactiae, and Cutibacterium
acnes) were run on the MiQLab. Cultures were incubated and grown
between 24 to 72 hours, diluted 10-fold, and run on the MiQLab,
which reported no false positives, validating very high specificity
for the Mycoplasma Test.
LexaGene’s results demonstrate that the MiQLab
system can serve as a valid alternative to lengthy traditional
methods for mycoplasma detection. Given the MiQLab can be up to 300
times faster than traditional culture testing (~2 hours versus ~28
days) for a definitive result, the MiQLab can provide a significant
time advantage for biopharmaceutical manufacturers.
To learn more about LexaGene and the MiQLab
System, 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
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. Cossar D. Bioprocessing techniques. Published
online 2019.2. Clapp KP, Castan A, Lindskog EK. Chapter 24 -
Upstream Processing Equipment. In: Jagschies G, Lindskog E, Łącki
K, Galliher PBT-BP, eds. Elsevier; 2018:457-476. 3. Nikfarjam L,
Farzaneh P. Prevention and detection of Mycoplasma contamination in
cell culture. Cell J. 2012;13(4):203-212. 4.
https://www.biopharminternational.com/view/usp-mycoplasma-tests-new-regulation-mycoplasma-testing
5. Barone PW, Wiebe ME, Leung JC, et al. Viral contamination in
biologic manufacture and implications for emerging therapies. Nat
Biotechnol. 2020;38(5):563-572.6. Kong F, James G, Gordon S,
Zelynski A, Gilbert GL. Species-specific PCR for identification of
common contaminant mollicutes in cell culture. Appl Environ
Microbiol. 2001;67(7):3195-3200.
Corporate Contact:
Gail Winslow
Director of Corporate Marketing
gwinslow@lexagene.com
978.482.6237
ir@lexagene.com
800.215.1824
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