Mr. Phil Casselli reports

MICROBIX & ULISSE BIOMED COLLABORATE ON HPV CONTROLS & ASSAYS

Microbix Biosystems Inc. is collaborating with Ulisse Biomed SpA, a company developing innovative diagnostics, theranostics and therapeutics. 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 (that is, polymerase chain reaction (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 subtypes of virus, of which 14 are directly implicated to cause human cancers -- most notably cervical tumours. 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 tumours. 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 bCUBE, a miniaturized PCR instrument particularly suitable for small to 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 continuing 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.

Phil Casselli, senior vice-president of business development at Microbix, commented: "We met the Ulisse senior team at a conference in Europe. Shortly thereafter we began working with them as they finalized the performance evaluation of their assays. We are proud to be selected as their preferred controls and to be referenced on their IFUs. This is another success as we bring these sophisticated high-risk HPV control products to the global markets for HPV screening."

Bruna Marini, chief operating officer of Ulisse, also commented: "We were looking for a set of controls that fully covered the range of high-risk HPV types and Microbix is the only company to have such a portfolio. After an extensive evaluation process, we concluded the performance of Microbix QAPs are exactly what Ulisse needs and the interactions with their team are delightful."

About Microbix Biosystems Inc.

Microbix Biosystems creates proprietary biological products for human health, with over 100 skilled employees and annualized sales targeting $2-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 10 international distributors. Microbix is ISO 9001 and 13485 accredited, U.S. Food and Drug Administration registered, Australian Therapeutic Goods Administration registered, and Health Canada establishment licensed, and provides CE marked products.

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