Microbix Biosystems Inc. announced a collaboration with Ulisse Biomed S.p.A. The companies are collaborating to make Microbix?s Quality Assessment Products (?QAPs??) available and optimized to support the clinical use and accuracy of Ulisse molecular tests for high-risk types of Human Papilloma Virus (?HPV Assays?). Molecular (i.e., ?PCR?) HPV Assays are used to diagnose infections and distinguish between the virus types that generate higher or lower risks of fatal cancers. HPV is a family of approximately 100 sub-types of virus, of which 14 are directly implicated to cause human cancers ?

most notably cervical tumors. Molecular tests for high-risk types of HPV identify at-risk patients years before cancers arise, thereby permitting them to be carefully monitored to prevent the development of invasive and potentially lethal tumors. However, HPV Assays must be stringently monitored to ensure their accuracy ?

ideally with Microbix QAPs. Ulisse has obtained EU ?CE mark? approval for its high-risk extended genotype HPV Assays, which will now be commercialized on an automated sample-to-result closed system with an installed base of over 1,500 instruments.

Moreover, Ulisse?s HPV Assays are validated with the most widely used open platforms and with Hyris bCUBETM, a miniaturized PCR instrument particularly suitable for small-medium laboratories that Ulisse is proposing to clients in conjunction with its assays. Ulisse has validated Microbix?s HPV QAPs as tools to support the ongoing accuracy of its HPV Assays and will recommend their usage in its instructions for use (?IFUs?). Additionally, Microbix has created custom ONBOARDx?

kits of QAPs to assist the Ulisse sales teams in demonstrating the HPV Assays to prospective customers, as well as for training operators and for qualifying new HPV Assay installations.