Validation for use with Self-Collected Samples across Multiple Assays and Media

MISSISSAUGA, Ontario, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix), a life sciences innovator, manufacturer, and exporter, announces that key opinion leader ("KOL") collaborators are presenting results of a Microbix Quality Assessment Product ("QAP") for controlling testing for high-risk types of Human Papilloma Virus ("HPV") at the 36th annual International Papillomavirus Conference ("IPVC") taking place in Edinburgh, Scotland, November 12 to 15, 2024.

IPVC is the annual conference of the International Papillomavirus Society ("IVPS"), a not-for-profit organization of biomedical scientists investigating human and animal papillomaviruses and their associated diseases. IPVS is the global authority on papillomaviruses and its mission is to contribute to the elimination of papillomavirus-related diseases. HPV is best known as the undisputed cause of cervical cancer in women, driven by long-term infection with one or more high-risk types of the virus family.

When properly validated and controlled, molecular (e.g., PCR-based) testing for HPV infection enables cervical cancer screening programs to identify at-risk patients years before the development of invasive cancer. Furthermore, cervical cancer screening programs can increase participation rates by enabling women to "self-collect" samples in the privacy of their homes, rather than remaining reliant on whether every at-risk women has ready access to medical professionals to collect their samples.

At IPVC, authors Willem Ford, Marco Ho Ting Keung, and David Hawkes will present their poster titled "Validation of Commercial FLOQSwab Quality Control for Human papillomavirus detection on six ISO 15189 accredited self-collection methods." Their aim was to examine the compatibility of Microbix's PROCEEDxFLOQ (HPV 16/18/45) QAP (RUO) to support testing for the three most common high-risk types of HPV and assess its viability as a quality control ("QC") product.

Their work tested use of this Microbix QAP with two commonly-used liquid media and six commercial and clinically-validated HPV assays. The results indicate that this QAP could be used for effective estimation of sensitivity, specificity, and both negative and positive predictive values with different self-collection methods and has a 100% concordance with detection across the two media types and for all six HPV assays. The authors concluded that the PROCEEDxFLOQ (HPV 16/18/45) "has excellent analytical performance and provides a QC product for use by laboratories processing self-collection using methods involving the Copan FLOQSwab." The full Poster will be made available at following its presentation at IPVC.

Microbix thanks Professor David Hawkes, the Australian Centre for the Prevention of Cervical Cancer, the University of Melbourne (Australia), and the University of Malaya (Malaysia) for conducting this work.

Purchase enquiries for Microbix QAPs can be e-mailed to customer.service@microbix.com.

About Microbix Biosystems Inc.
Microbix Biosystems Inc. creates proprietary biological products for human health, with over 100 skilled employees and sales now targeting C$ 2.0 million per month. It makes and exports 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 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 Kinlytic urokinase, a biologic thrombolytic drug used to treat blood clots, and reagents or media to support molecular diagnostic testing (e.g., its DxTM for patient-sample collection). 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 IPVC and IPVS, the Poster, the HPV QAPs, or their relevance, Microbix's or others' products or services, business and business results, goals or outlook, risks associated with financial results and stability, development projects such as those referenced in its presentations, regulatory compliance and approvals, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity or timeliness of delivery), currency exchange rates, maintaining adequate working capital or raising new capital on acceptable terms or at all, and other similar statements about 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. Microbix cautions that all forward-looking information is inherently uncertain and actual performance may be affected by a number of material factors, many of which are beyond its 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 Microbix's judgement as of the date of this new release, and it is under no obligation to update or alter any forward-looking information.

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Microbix, DxTM, Kinlytic, PROCEEDx and QAPs are trademarks of Microbix Biosystems Inc.
PROCEEDxFLOQ is a trademark of Microbix Biosystems Inc. in collaboration with Copan Italia S.p.A
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