LexaGene Holdings, Inc., (OTCQB: LXXGF; TSX-V: LXG)
(“LexaGene”), a molecular diagnostics company that has
commercialized an instrument for automated multiplex PCR testing,
today announced it has successfully expanded its bio-pharmaceutical
(“bio-pharma”) contamination panel by developing a Burkholderia1
test for use on its MiQLab™ System.
Burkholderia cepacia complex, a group of about 24 related
environmental bacteria, is a problem contaminant for the bio-pharma
industry. B. cepacia is the most common microbial contaminant in
nonsterile pharmaceutical products accounting for up to 39 percent
of product contamination.2 In July 2021, the FDA3 advised drug
manufacturers to test for Burkholderia, which has increasingly been
found to be the cause of recalled products, including a skin gel,4
an ultrasound gel,5 and a mouthwash.6 Recently, following two
deaths in the United States, an aromatherapy room spray7 was
recalled due to contamination with Burkholderia pseudomallei (B.
pseudomallei). This bacterium is classified by the Centers for
Disease Control and Prevention (CDC) as a Tier 1 biothreat agent,
because it can be easily aerosolized and made into a bioweapon.8 B.
pseudomallei is endemic in the tropics, has a mortality rate of
sometimes greater than 40 percent, and kills ~90,000 people
annually worldwide.9,10
Dr. Jack Regan, LexaGene’s CEO and Founder stated, “LexaGene is
increasingly bullish over the opportunities in the bio-pharma
market. The more we talk to this industry, the more we recognize
how much value the LexaGene MiQLab System can provide for rapid and
sensitive detection of contaminants. To meet the new FDA
recommendations, we have quickly developed a genus level
Burkholderia test that can also detect the rare events of
contamination with the biothreat agent B. pseudomallei and continue
to develop other tests to provide the best, most complete,
multiplexed PCR testing solution for this industry.”
Bio-pharmaceutical manufacturing companies frequently test for
contamination to avoid having a recall, as these events can cost
tens of millions of dollars in investigation, cleanup, corrective
actions, lost revenue, and manufacturing plant downtime.11,12 The
list of possible bio-pharma contaminants is long, with many
requiring custom culture conditions for optimal growth. Even under
optimal growth conditions, some contaminants take up to 28 days for
testing.13 In contrast, PCR-based testing does not require
specialized culture conditions and can be performed immediately –
providing results in hours rather than weeks. The time savings that
can be realized, using the MiQLab, can have massive implications
for bio-pharmaceutical manufacturers by allowing them to more
quickly identify contaminants before they result in millions of
dollars in losses.
The bio-pharma industry is increasingly looking for flexible PCR
solutions to handle complex matrices and report back results
quickly. LexaGene’s MiQLab System has already been tested and
proven to work well on some of the most common cell lines and
products manufactured in the industry. LexaGene has already sold
its MiQLab into this industry and continues to expand its
offering.
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
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://en.wikipedia.org/wiki/Burkholderia
2
https://medcraveonline.com/IJVV/burkholderia-cepacia-in-pharmaceutical-industries.html
3
https://www.fda.gov/drugs/drug-safety-and-availability/fda-advises-drug-manufacturers-burkholderia-cepacia-complex-poses-contamination-risk-non-sterile
4
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mpm-medical-llc-issues-voluntary-nationwide-recall-regenecare-ha-hydrogel-due-burkholderia-cepecia
5 Eco-Med Pharmaceutical Issues Voluntary Recall of Eco-Gel 200.
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/eco-med-pharmaceutical-issues-voluntary-recall-eco-gel-200
6 Lohxa Recalls of Chlorhexidine Gluconate Oral Rinse USP.
https://www.rttnews.com/3144807/lohxa-recalls-of-chlorhexidine-gluconate-oral-rinse-usp.aspx?type=fdr
7 Walmart Recalls Certain Room Spray Following Two Deaths.
https://markets.businessinsider.com/news/stocks/walmart-recalls-certain-room-spray-following-two-deaths-1030893880
8 Security Plan Guidance: Section 11(f) – Tier 1 Security.
https://www.selectagents.gov/compliance/guidance/security-plan/section11f.htm
9 Dawson P, Duwell MM, Elrod MG, et al. Human Melioidosis Caused
by Novel Transmission of Burkholderia pseudomallei from Freshwater
Home Aquarium, United States Emerg Infect Dis. 2021;27(12).
10 Wiersinga WJ, Virk HS, Torres AG, et al. Melioidosis. Nat Rev
Dis Prim. 2018;4(1):17107. doi:10.1038/nrdp.2017.107
11 https://www.nature.com/articles/s41587-020-0507-2
12 Liu, S. et al. Development and qualification of a novel virus
removal filter for cell culture applications. Biotechnol. Prog. 16,
425–434 (2000).
13
https://www.biopharminternational.com/view/usp-mycoplasma-tests-new-regulation-mycoplasma-testing
Corporate & Media Contact:
Gail Winslow
Director, Marketing
gwinslow@lexagene.com
978.482.6237
Investors:
ir@lexagene.com
800.215.1824
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