Microbix Biosystems Inc. (
TSX: MBX, OTCQX: MBXBF,
Microbix®), a life sciences innovator, manufacturer, and
exporter, announces that Labquality Ltd., a collaborator and
customer, is presenting results of its use of Microbix Quality
Assessment Products (“
QAPs™”) for accreditation of
clinical labs for conducting molecular (“
MDx”)
tests for antimicrobial-resistant (“
AMR”) strains
of M. genitalium (“
Mgen”), a common
sexually-transmitted infection (“
STI”).
The poster presentation of results will be made
at ECCMID 2024, the European Congress of Clinical Microbiology and
Infectious Diseases taking place in Barcelona, Spain from April 27
to 30, 2024. The poster is titled “Mycoplasma genitalium, Drug
Resistance, Nucleic Acid Detection; Introducing a New External
Quality Assessment Scheme” and was authored by scientists from both
Labquality and Microbix.
Mgen is a common STI in both men and women who
have been sexually-active. Left untreated, Mgen is known to cause
chronic health problems in women, such as chronic pain, ectopic
pregnancy, infertility, and pelvic inflammatory disease, and
non-gonococcal urethritis in men. As many as 50% of Mgen infections
can be resistant to first-line antibiotic treatments. Tests for
Mgen were not commonly conducted until the past several years, in
part due to the unavailability of controls (e.g., QAPs) to assess
and validate the accuracy of tests for antibiotic-susceptible and
AMR strains of this bacteria.
As testing for Mgen and AMR Mgen infections
becomes more widespread, external quality assessment
(“EQA”) programs are needed to evaluate the
proficiency of clinical labs and provide them accreditation to test
patient-samples. The poster presents results of a Labquality
program evaluating the proficiency of 38 clinical labs in their use
of 16 different MDx assays (12 commercial & 4 lab-developed).
Each clinical lab was evaluated for its ability to detect (i) Mgen,
and (ii) an Mgen-related marker of resistance to macrolide
antibiotics. It was found that (i) the Microbix Mgen QAPs
(positives & negatives) were well-suited for this usage, (ii)
the performance of labs and assays was excellent, (iii) specific
reporting guidelines are needed to avoid errors, and (iv) there is
a need for such an EQA program to support Mgen testing.
Microbix developed its Mgen QAPs to resemble
patient specimens, support the whole testing process, and contain
all possible MDx test targets – buffered and desiccated onto a
Copan® FLOQSwab® to ensure multi-year product stability at room
temperature. The pilot EQA program confirmed the performance of
these QAPs across all clinical labs, instrument platforms, and
assays. These Mgen QAPs are now available from Microbix as part of
its PROCEEDx®FLOQ® (RUO) or REDx™FLOQ® (IVD) catalogue of
products.
Enquiries regarding the EQA program being
developed by Labquality to qualify and support clinical
laboratories in molecular testing for Mgen and AMR Mgen should be
directed to Ms. Kati Luiro, EQA Coordinator, at
kati.luiro@labquality.com, info@labquality.com, or via its website
www.labquality.com. Purchase enquiries for these or other Microbix
QAPs can be e-mailed to customer.service@microbix.com.
About Microbix Biosystems
Inc.Microbix Biosystems Inc. creates proprietary
biological products for human health, with over 100 skilled
employees and annualized revenues approaching C$ 2.0 million per
month. It enables the worldwide commercialization of diagnostic
assays by making a wide range of critical ingredients and devices
for the global diagnostics industry, notably antigens for
immunoassays and its laboratory quality assessment products (QAPs™)
that support clinical lab proficiency testing, enable assay
development and validation, or help ensure the quality of clinical
diagnostic workflows. Its antigens drive the antibody tests of
approximately 100 diagnostics makers, while QAPs are sold to
clinical lab accreditation organizations, diagnostics companies,
and clinical labs. Microbix QAPs are now available in over 30
countries, supported by a network of international distributors.
Microbix is ISO 9001 & 13485 accredited, U.S. FDA registered,
Australian TGA registered, Health Canada establishment licensed,
and provides CE marked products.
Microbix also applies its biological expertise
and infrastructure to develop other proprietary products and
technologies, most notably Kinlytic® urokinase, a biologic
thrombolytic drug used to treat blood clots, and reagents or media
to support molecular diagnostic testing (e.g., its DxTM™ for
patient-sample collection). Microbix is traded on the TSX and
OTCQX, and headquartered in Mississauga, Ontario, Canada.
Forward-Looking InformationThis
news release includes “forward-looking information,” as such term
is defined in applicable securities laws. Forward-looking
information includes, without limitation, discussion of Labquality
or its EQA schemes, the Poster, the Mgen QAPs, or their relevance,
Microbix’s or others’ products or services, business and business
results, goals or outlook, risks associated with financial results
and stability, development projects such as those referenced in its
presentations, regulatory compliance and approvals, sales to
foreign jurisdictions, engineering and construction, production
(including control over costs, quality, quantity or timeliness of
delivery), currency exchange rates, maintaining adequate working
capital or raising new capital on acceptable terms or at all, and
other similar statements about anticipated future events,
conditions or results that are not historical facts. These
statements reflect management’s current estimates, beliefs,
intentions, and expectations; they are not guarantees of future
performance. Microbix cautions that all forward-looking information
is inherently uncertain and actual performance may be affected by
many material factors, some of which are beyond its control.
Accordingly, actual future events, conditions and results may
differ materially from the estimates, beliefs, intentions, and
expectations expressed or implied in the forward-looking
information. All statements are made as of the date of this news
release and represent Microbix’s judgement as of the date of this
new release, and it is under no obligation to update or alter any
forward-looking information.
Please visit https://microbix.com or
https://www.sedarplus.ca for recent Microbix news and filings.
For further information, please contact Microbix
at:
Cameron Groome, CEO(905) 361-8910 |
Jim Currie, CFO(905) 361-8910 |
Deborah Honig, Investor RelationsAdelaide Capital Markets(647)
203-8793 ir@microbix.com |
|
Copyright © 2024 Microbix Biosystems Inc.
Microbix®, DxTM™, Kinlytic®, PROCEEDx®, QAPs™, and REDx™ are
trademarks of Microbix Biosystems Inc.PROCEEDx®FLOQ® and REDx™FLOQ®
are trademarks of Microbix Biosystems Inc. in collaboration with
Copan Italia S.p.A.Copan®, FLOQ®, and FLOQSwab® are trademarks of
Copan Italia S.p.A.Other companies’ names and products are
protected by their respective trademarks.
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