Microbix QAPs Supporting HPV Testing Across The Netherlands

MISSISSAUGA, Ontario, July 05, 2023 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix^®), a life sciences innovator, manufacturer, and exporter, announces that its quality assessment products ("QAPstm") 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 CORtm system and its Onclaritytm 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 Biosystems
Microbix 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 (QAPstm) 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 (DxTMtm) 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 Information
This 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.

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Microbix^®, DxTMtm, Kinlytic^®, QAPstm, and REDxtm are trademarks of Microbix Biosystems Inc.
CORtm and Onclaritytm are trademarks of Becton, Dickinson and Company