Microbix Biosystems Inc. (
TSX: MBX, OTCQX: MBXBF,
Microbix®), a life sciences innovator, manufacturer, and
exporter, announces that its quality assessment products
(“
QAPs™”) are supporting a testing program for
Human Papilloma Virus (“
HPV”) using molecular
diagnostic (“
MDx”) technology at Dublin’s The
Coombe Hospital, in the Republic of Ireland, an EU member-state.
Microbix’s local distribution partner, The
Medical Supply Company of Ireland (“MSC”), has
secured a tender-based contract to supply goods and services to
support this national-level MDx and HPV-based cervical cancer
screening program. The program is being driven by the
instrumentation and reagents of the Roche Diagnostics Corporation
cobas® 6800/8800 Systems and cobas® HPV test system, with Microbix
REDx® liquid-format IVD-regulated multiplex QAPs providing quality
management system support to help ensure test accuracy. It is
expected that the program will see regular participation by a
majority of women of reproductive age within Ireland’s overall
population of 5.1 million.
HPV is a family of over 100 virus sub-types, 14
of which are deemed “high-risk” as they may directly cause cancers,
most notably cervical cancer, if not resolved by the immune system.
Most sexually-active adults become infected with one or more HPV
types and such infections can be persistent. MDx tests permit early
detection and timely preventative healthcare by identifying those
at-risk years before cancer develops.
However, MDx-based screening programs require
rigorous quality systems and ongoing revalidation to ensure their
accuracy. This includes creating workflow algorithms, implementing
strict QC/QA practices, training staff to be proficient, and
sourcing materials and methods to evaluate testing workflows.
Microbix’s portfolio of HPV-directed QAPs are used to help ensure
the ongoing accuracy of MDx testing.
Dr. Lisa Tang, Head of Sales and Marketing of
MSC commented, “We are pleased to support this important women’s
health initiative with Microbix’s HPV QAPs. We now look forward to
the roll-out of MDx-based cervical cancer screening throughout the
Republic of Ireland.”
An initial purchase order for HPV-directed QAPs
has been received by Microbix and it is expected that recurring
QAPs sales into Ireland will become routine. Microbix and its
distribution partners are likewise targeting support of MDx and
HPV-based cervical cancer screening programs in other countries,
including within the EU and in North America.
Phil Casselli, Senior Vice President of Sales
and Business Development of Microbix also commented, “Ireland
provides an example of Microbix’s technological leadership by way
of our HPV quality controls being selected to support another
national HPV screening program. We are proud to have collaborated
with Coombes, MSC, and Roche to help bring this program
online.”
About Microbix
BiosystemsMicrobix Biosystems Inc. creates proprietary
biological products for human health, with over 100 skilled
employees and annualized sales targeting C$ 2.0 million per month.
It makes 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 10 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 viral transport medium (DxTM™) to
stabilize patient samples for lab-based molecular diagnostic
testing and Kinlytic® urokinase, a biologic thrombolytic drug used
to treat blood clots. 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 Coombes,
MSC, Roche, or any MDx screening programs, MDx testing for HPV or
its relevance, the products or services of Microbix, Microbix’s
business and business results, goals or outlook, risks associated
with financial results and stability, development projects such as
those referenced in its corporate presentation, regulatory
compliance and approvals, sales to foreign jurisdictions,
engineering and construction, production (including control over
costs, quality, quantity and timeliness of delivery), foreign
currency and exchange rates, maintaining adequate working capital
or raising further capital on acceptable terms or at all, and other
similar statements concerning 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. The
Company cautions that all forward-looking information is inherently
uncertain and that actual performance may be affected by many
material factors, some of which are beyond the Company’s 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 the Company’s judgement as of the date of
this new release, and the Company 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)
203-8793ir@microbix.com |
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Copyright © 2023 Microbix Biosystems Inc.
Microbix®, DxTM™, Kinlytic®, QAPs™, and REDx™ are trademarks of
Microbix Biosystems Inc.Other companies’ names and products are
protected by their respective trademarks.
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