Microbix Biosystems Inc. (
TSX: MBX, OTCQX: MBXBF,
Microbix®), a life sciences innovator, manufacturer, and
exporter, announces that it is presenting results of a novel
Quality Assessment Product (“
QAP™”) for supporting
Point-of-Care-Tests (“
POCTs”) for infection with
the Hepatitis C Virus (“
HCV”) at the American
Diagnostic and Laboratory Medicine (“
ADLM”)
conference taking place in Chicago, Illinois July 29 to August 1,
2024.
At ADLM, Microbix will exhibit alongside leading
firms that provide tests to diagnose and direct treatment of HCV
and many other infectious diseases. Microbix will thereby showcase
its ever-growing portfolio of QAPs that help ensure the accuracy of
antigen and molecular (i.e., “PCR”) tests and
their workflows.
Also at ADLM, Microbix will present its poster
titled “Novel Hepatitis C Virus External Quality Control that is
Stable at Ambient Temperature and Suitable for Use in Low-Resource
Settings.” The poster reviews the performance of a novel
PROCEED®FLOQ® (RUO) QAP to support the training for and prospective
quality management of POCT PCR tests that use fingerstick
whole-blood samples to detect HCV. Following presentation of the
poster on the afternoon of July 30, it will be made available at
https://microbix.com.
In spite of efforts to eliminate viral
hepatitis, it is estimated that 58 million individuals are infected
with HCV. The majority of such persons live where conventional
lab-based diagnostics are inaccessible due to high costs, want of
equipment or trained personnel, or lack of “cold-chain”
refrigeration. HCV POCTs are therefore critical for improving test
accessibility, surveillance, and treatment, with such POCTs
requiring suitably designed and robust External Quality Controls
(e.g., QAPs) to monitor the accuracy of testing.
The novel Microbix HCV QAP is formatted onto a
COPAN® FLOQSwab® to help achieve a consistent and accurate signal,
provide room-temperature stability, and be superior to conventional
HCV quality controls that must be kept frozen until use. The QAP is
also whole-genome to contain all relevant PCR-test targets, works
with the relevant sample-elution reagents, and has long-term
stability at ambient temperatures (i.e., 2 to 30 ºC). This QAP is
intended to facilitate and accelerate the rollout and adoption of
POCTs for HCV, particularly for geographically or
culturally-isolated persons and in low or middle-income
countries.
Amer Alagic, Microbix’s Director of R&D and
a co-author of the poster commented, “We believe this PROCEEDxFLOQ
QAP is the first swab-based and room-temperature stable control for
HCV POCTs. Our Microbix team is pleased to again be speeding-up the
responsible rollout of tests for high-impact infectious diseases
such as HCV and thereby reducing its individual and global health
burden.”
Microbix gratefully acknowledges three external
collaborators on this work, namely Flinders University (Australia),
BioQControl (The Netherlands), and Cepheid Inc. (United
States).
Purchase enquiries for all 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 sales now targeting C$ 2.0 million per
month. It makes and exports 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 ADLM, the
Poster, the HCV 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 a
number of material factors, many 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 www.sedar.com
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®, and QAPs™ are trademarks of
Microbix Biosystems Inc.PROCEEDx®FLOQ® is a trademark 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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