QAPs for HPV Test Verification within Cervical Cancer Screening Program

MISSISSAUGA, CANADA, February 6, 2023 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces that it will be presenting results of its collaboration with the Microbiology Laboratory of the Queen Elizabeth Hospital of Health PEI (“Health PEI”), in support of provincial adoption of molecular diagnostic (“MDx”) screening for Human Papillomavirus (“HPV”) infections – at the annual congress of the European Research Organization on Genital Infections and Neoplasia (“EUROGIN”), taking place in Bilbao, Spain from February 8 to 11, 2023.

Prince Edward Island (“PEI”) is the first Canadian Province to undertake full implementation of MDx HPV testing to improve cervical cancer screening from the pathology-based “Pap Tests.” Directly testing for HPV provides earlier and more reliable detection of infections that are at higher risk of progression to cervical cancer, thereby helping to prevent deaths, illness, and healthcare costs.  Microbix’s Quality Assessment Products (“QAPs™”) supporting test and test-workflow accuracy enabled it to assist Health PEI in verifying functionality and implementing use of the Becton Dickinson (“BD”) Onclarity™ HPV assay.

The poster being presented at EUROGIN is titled “Performance of High-Risk HPV Single Analyte and Multiplex Panel External Quality Controls for Verification of Extended Genotyping on the BD Onclarity™ HPV Assay.” The poster details precisely how QAPs supported verification of these HPV tests and Microbix gratefully acknowledges the work and support of its collaborators in PEI and at BD. The poster will be available on Microbix’s website (https://microbix.com) and from EUROGIN following its presentation.

At EUROGIN, Microbix will also exhibit its portfolio of HPV QAPs, comprised of single-analyte products covering 9 high-risk and 1 low-risk types, and 3 multiplexes for “extended genotyping” of additional high-risk types. Microbix HPV QAPs are available for sale in Canada, Australia, Europe, the United States, and other jurisdictions under its “REDx™ Controls” (IVD) or “PROCEEDx™” (RUO) brand names.

Most sexually-active adults become infected with one or more types of HPV and if not cleared, its high-risk types are firmly established as the cause for development of various cancers, of which cervical cancer is one. Diagnostic tests to detect infection with high-risk HPV provide important preventative health information and require validated, regulated, and third-party test-controls to help ensure their accuracy.

MDx-based HPV screening programs can identify at-risk individuals years before cancerous cells can be detected using pathology. Such programs were delayed due to testing capacity limitations during the height of the pandemic, but are now being resumed. Microbix believes high-risk HPV infections and resulting cancers have gone undiagnosed and is pleased to help enable new MDx screening programs. Purchase enquires for Microbix’s products or services can be directed to customer.service@microbix.com.

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 (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 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 Health PEI, BD, or EUROGIN, the poster or its relevance, the products of Microbix or its collaborators, Microbix’s business and business results, goals or outlook, risks associated with financial results and stability, development projects such as those referenced herein or  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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Copyright © 2023 Microbix Biosystems Inc.     

Microbix®, DxTM™, Kinlytic®, PROCEEDx™, QAPs™, REDx™ and REDx™ Controls are trademarks of Microbix Biosystems Inc.

BD Onclarity™ is a trademark of Becton Dickinson and Company or an affiliate.