Mr. Cameron Groome reports

MICROBIX QAPS SUPPORTING HPV TESTING ACROSS THE NETHERLANDS

Microbix Biosystems Inc.'s 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, a European Union 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 (in vitro diagnostics)-regulated QAPs will be used to support the quality management system monitoring the continuing accuracy of laboratory performance for the program. The program will invite women between the ages of 30 and 60 within the Dutch population of approximately 17.8 million.

HPV is a family of over 100 virus subtypes, 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 health care by identifying those at-risk years before cancer develops.

However, MDx-based screening programs require rigorous quality systems and continual monitoring of test accuracy, in particular when performed in multiple laboratories and using multiple equipment lines. This includes creating workflow algorithms, implementing strict quality assurance/quality control (QA/QC) 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 continuing accuracy of MDx testing.

Dr. Andreas Simons, director of project management clinical diagnostics for 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 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 health care 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 Inc.

Microbix Biosystems creates proprietary biological products for human health, with over 100 skilled employees and annualized sales targeting $2-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, 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, United States Food and Drug Administration registered, Australian Therapeutic Goods Administration 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 headquartered in Mississauga, Ont., Canada.

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