Microbix Biosystems Inc. (
TSX: MBX, OTCQX: MBXBF,
Microbix®), a life sciences innovator, manufacturer, and
exporter, announces that its quality assessment products
(“
QAPs™”) have been selected to support a
screening program for Human Papilloma Virus
(“
HPV”) using molecular diagnostic
(“
MDx”) technology across The Netherlands, an EU
member-state.
Microbix’s local distribution partner,
R-Biopharm, has secured a tendered contract to supply goods and
services to support this national-level HPV-based cervical cancer
screening program. The program is being driven by the
instrumentation and reagents of the BD COR™ system and its
Onclarity™ HPV assay. Microbix REDx® liquid-format IVD-regulated
QAPs will be used to support the quality management system
monitoring the ongoing accuracy of laboratory performance for the
program. The program will invite women between the ages of 30 to 60
within the Dutch population of approximately 17.8 million.
HPV is a family of over 100 virus sub-types, 14
of which are deemed “high-risk” as they may 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 monitoring of test accuracy,
in particular when performed in multiple laboratories and using
multiple equipment lines. 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. Andreas Simons, Director, Project Management
Clinical Diagnostics of R-Biopharm stated, “It’s a pleasure to
support this important women’s health initiative of the Dutch
national screening agency, Bevolkingsonderzoek Nederland. The next
contract period of this primary cervical cancer screening program
is now beginning, with its quality management supported by
R-Biopharm and Microbix’s QAPs.”
An initial order for HPV-directed QAPs has been
shipped by Microbix and it is expected that its QAPs sales under
this tender contract will reach several hundred thousand Canadian
Dollars. Microbix and its distribution partners are likewise
targeting to support MDx and HPV-based cervical cancer screening
programs in other countries across the EU and in North America.
Dr. Rob Schuurman, National Reference Officer
for the Dutch Cervical Cancer Screening Program (BVO), noted “MDx
testing for HPV improves cervical cancer screening by identifying
those at-risk efficiently. Close monitoring of the entire HPV
testing workflow is critical to realizing this healthcare goal and
Microbix’s HPV QAPs have been selected to support the quality
assessment monitoring of the molecular testing process, a vital
part of BVO’s quality management system.”
About Microbix
BiosystemsMicrobix 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 laboratory accreditation
organizations, diagnostics companies, and clinical laboratories.
Microbix QAPs are now available in over 30 countries, distributed
by 1WA (Oneworld Accuracy Inc.), Alpha-Tec Systems, Inc.,
Diagnostic International Distribution SpA., Labquality Oy, The
Medical Supply Company of Ireland, Neo-Science Equipment LLC,
R-Biopharm AG, SDT Molecular Pte Ltd, Seegene Canada Inc., and
Thomas Scientific LLC. Microbix is ISO 9001 and 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 any
customer or distributor herein, or any MDx-based 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 a number of material factors, many
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 |
Copyright © 2023 Microbix Biosystems Inc.
Microbix®, DxTM™, Kinlytic®, QAPs™, and REDx™ are trademarks of
Microbix Biosystems Inc.COR™ and Onclarity™ are trademarks of
Becton, Dickinson and Company
Microbix Biosystems (TSX:MBX)
Historical Stock Chart
From Dec 2024 to Jan 2025
Microbix Biosystems (TSX:MBX)
Historical Stock Chart
From Jan 2024 to Jan 2025