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

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.