Mr. Cameron Groome reports

MICROBIX QAPS SUPPORTING HPV TESTING IN IRELAND

Microbix Biosystems Inc.'s quality assessment products (QAPs) are supporting a testing program for human papilloma virus (HPV) using molecular diagnostic (MDx) technology at Dublin's The Coombe Hospital, in the Republic of Ireland, a European Union member-state.

Microbix's local distribution partner, The Medical Supply Company of Ireland (MSC), has secured a tender-based contract to supply goods and services to support this national-level MDx and HPV-based cervical cancer screening program. The program is being driven by the instrumentation and reagents of the Roche Diagnostics Corp. cobas 6800/8800 systems and cobas HPV test system, with Microbix REDx liquid-format IVD (in vitro diagnostics)-regulated multiplex QAPs providing quality management system support to help ensure test accuracy. It is expected that the program will see regular participation by a majority of women of reproductive age within Ireland's overall population of 5.1 million.

HPV is a family of over 100 virus subtypes, 14 of which are deemed high-risk as they may directly cause cancers, most notably cervical cancer, if not resolved by the immune system. Most sexually active adults become infected with one or more HPV types and such infections can be persistent. MDx tests permit early detection and timely preventative health care by identifying those at risk years before cancer develops.

However, MDx-based screening programs require rigorous quality systems and continuing revalidation to ensure their accuracy. This includes creating workflow algorithms, implementing strict quality assurance/quality control (QA/QC) practices, training staff to be proficient, and sourcing materials and methods to evaluate testing workflows. Microbix's portfolio of HPV-directed QAPs are used to help ensure the continuing accuracy of MDx testing.

Dr. Lisa Tang, head of sales and marketing of MSC, commented: "We are pleased to support this important women's health initiative with Microbix's HPV QAPs. We now look forward to the rollout of MDx-based cervical cancer screening throughout the Republic of Ireland."

An initial purchase order for HPV-directed QAPs has been received by Microbix and it is expected that recurring QAPs sales into Ireland will become routine. Microbix and its distribution partners are likewise targeting support of MDx and HPV-based cervical cancer screening programs in other countries, including within the European Union and in North America.

Phil Casselli, senior vice-president of sales and business development of Microbix, also commented: "Ireland provides an example of Microbix's technological leadership by way of our HPV quality controls being selected to support another national HPV-screening program. We are proud to have collaborated with Coombes, MSC and Roche to help bring this program on-line."

About Microbix Biosystems Inc.

Microbix Biosystems creates proprietary biological products for human health, with over 100 skilled employees and annualized sales now 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.

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, Ont., Canada.

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