Microbix Unveils Test Controls for Head and Neck Cancer

HPV-related Tissue-Sample Mimics for QC of histology and PCR analyses

MISSISSAUGA, Ontario, March 11, 2024 (GLOBE NEWSWIRE) — Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix^®), a life sciences innovator, manufacturer, and exporter, announces that it is presenting results of Quality Assessment Products (“QAPs™”) for supporting the quality control (“QC”) of histology and PCR-based tests driven by tissue-samples of Head and Neck cancer caused by human papilloma virus (“HPV”). Its results presentation will be made at EUROGIN 2024, an international collaborative conference and exhibition focused upon innovations in HPV research and global cancer solutions taking place in Stockholm, Sweden from March 13 to 16, 2024.

While HPV is best known for causing cancers of the cervix in women, this virus family also causes cancer in other bodily tissues. Such further types of HPV-driven cancer include those of the “Head and Neck,” collectively tumours inside and behind the nose, throughout the mouth (including the tongue, gums, and palate), all sections of the throat, and the voice box. Diagnosis of such cancers is made from tissue sample analyses that look for the presence of cancerous cells via histology and the presence of viral DNA by PCR.

Unfortunately, a lack of standardized and reproducible reference samples makes it challenging to control the recommended test workflows for diagnosing such cancers. Microbix and collaborators at Sunnybrook Health Sciences Centre and Dartmouth-Hitchcock Medical Center worked to address this need. Microbix developed homogenous and reproducible simulated-specimen paraffin blocks to monitor the accuracy and reliability of such testing, being presented via a poster titled “Evaluating Diagnostic Workflows for Oropharyngeal Squamous Cell Carcinoma Detection Using Simulated Specimens Mounted on Slides.”

The authors of the poster conclude that this QAP is innovative and clinically-relevant on multiple levels, namely that (i) these are the first simulated and standardized slides for use as prospective whole workflow QC materials for Head and Neck cancer reflex histology (IHC for p16) with follow up PCR-based confirmatory testing, and (ii) these prototype HPV-positive and HPV-negative contrived-specimen slides are homogeneous and reproducible QC materials that can be used to standardize inter-laboratory methodologies, monitor accuracy, and support new proficiency-testing and accreditation (EQA) schemes for laboratories conducting histologic and PCR test driven detection of such cancers.

Microbix will now work to optimize its tissue scaffold designs for supporting both histology and PCR workflows. These standardized and reproducible tissue-oriented test controls will then be added to Microbix’s catalogue of QAPs, expanding its activities into support of oncology workflows alongside its wide range of infectious disease test controls. The global market for diagnostic tests for cancer is currently estimated at US$ 18-20 billion, with a projected compound annual growth rate of over 10%.

Purchase enquiries for these and all 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 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 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 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 EUROGIN, the Poster, these latest 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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