Mr. Cameron Groome reports

MICROBIX & AUREVIA INTRODUCE NOVEL EQA SCHEME

Microbix Biosystems Inc. and Aurevia Oy, through its Labquality EQAS affiliate, have introduced a pilot external quality assessment (EQA) program to help clinical laboratories establish their proficiency at using molecular diagnostic methods (for example, PCR (polymerase chain reaction) tests) to diagnose bacterial vaginosis (BV).

BV is a common vaginal condition that will affect a large percentage of women during adulthood. BV is caused by an imbalance in the bacterial flora of the vagina, with non-beneficial species becoming dominant. BV has historically been diagnosed by changes in vaginal acidity or odour or by microbiology -- methods that are sometimes not definitive. In contrast, molecular diagnostic (MDx) tests can distinguish each of the organisms that should be present in vaginal flora and detect whether their proportions are normal. Accordingly, MDx tests for BV can provide definitive diagnoses and help determine a treatment plan.

The EQA program being introduced by Aurevia is No. 5305, titled "Bacterial vaginosis and vaginitis multiplex nucleic acid detection." The current pilot study is intended for clinical labs diagnosing BV as well as other vaginal infections such as vulvovaginal candidiasis and trichomoniasis. The program will be run with simulated samples made by Microbix (quality assessment products). After completion of the pilot study and analysis of its results, it is anticipated that a continuing program for BV will be added to the Aurevia Labquality EQAS portfolio of EQA schemes to which clinical laboratories testing for BV can subscribe.

Microbix QAPs are designed to fully emulate clinical specimens from patients while being safe and stable. For this BV pilot program, Microbix has created three QAP samples formatted onto Copan FLOQSwabs to correctly emulate the workflow of MDx tests for BV from collection of patient specimens through to the reporting of test results. Each of the three QAPs is non-infectious and, as for Microbix's full portfolio of PROCEEDxFLOQ and REDxFLOQ QAPs, is stable at room temperature for at least two years.

Heidi Berghall, EQA solutions manager, R&D (research and development), of Aurevia, commented: "It is important that emerging MDx tests for the diagnosis of BV are properly validated. With a proper EQA scheme to monitor labs' ongoing performance, such tests should improve access to care, ensure timely and accurate diagnosis, and help determine curative treatment. Aurevia is proud to be addressing these important clinical needs."

Cameron Groome, chief executive officer and president of Microbix, also commented: "It is a pleasure to work with global leaders like Aurevia to validate complex next-generation diagnostic tests, such as MDx tests for BV. Our objective is to be the leading partner for PT/EQA providers, test makers and clinical labs for providing QAPs to help ensure that their testing attains and sustains the highest possible levels of accuracy and quality assurance."

About Microbix Biosystems Inc.

Microbix Biosystems creates proprietary biological products for human health, with over 120 skilled employees and sales now targeting $2-million or more per month. It makes and exports 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 and ISO 13485 accredited, U.S. Food and Drug Administration registered, Australian Therapeutic Goods Administration registered, and Health Canada establishment licensed, and it provides IVDR-compliant (In Vitro Diagnostic Regulation) CE-marked (Conformite Europeene) products.

Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably Kinlytic urokinase, a biologic thrombolytic drug used to treat blood clots, and reagents or media to support molecular diagnostic testing (for example, its DxTM for patient-sample collection). Microbix is traded on the Toronto Stock Exchange and OTCQX and headquartered in Mississauga, Ont., Canada.

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