Mr. Cameron Groome reports

MICROBIX & API ENSURING FLU TESTS CAN DETECT H5N1 STRAIN

Microbix Biosystems Inc. and American Proficiency Institute (API), a groundbreaking supplier of proficiency testing (PT) to over 20,000 clinical laboratories, have started a pilot PT program to ensure that molecular diagnostic (MDx) assays can detect the emerging H5N1 strain of the influenza A virus.

Strains of the flu are named according to variations in the proteins that help them to infect host cells -- the hemagglutinin (H) protein and the neuraminidase (N) protein. There is a heightened risk of a pandemic when one or both of the H or N proteins have not been circulating in human populations. H5N1 is such a relatively novel strain of the flu virus, which has demonstrated the ability to infect birds, cattle and humans. H5N1 flu is now circulating on multiple continents and may become a new pandemic, with it having demonstrated a staggering rate of severe pneumonia and death across those infected thus far.

It is therefore critical to prove whether established MDx tests can accurately and reliably detect H5N1 flu. Such MDx flu tests include both regulator-approved assays and laboratory-developed tests, respectively classed as IVD and LDT. Clinical labs must objectively prove that every such assay they are using can reliably detect H5N1 flu -- requiring novel quality assessment products (QAPs) and new PT programs.

Microbix and API have been collaborating to fulfill this critical and urgent need. Using its virology and synthetic biology expertise, Microbix has created a novel QAP that provides the whole genome of H5N1 flu but which does not require use of nor contain any infectious materials. In turn, API is initiating a proficiency testing program whereby clinical labs can independently confirm their MDx assays and the established workflows in use will reliably detect H5N1 flu. This pilot PT program is now live, and API will invite a limited number of labs to participate before such a program is offered to all API clients.

Sue Harmer, president of API, commented: "API believes it is critical that we determine which widely used MDx assays can or can't reliably detect H5N1 flu. Such knowledge is critical for mounting an effective health system response to this emerging pandemic threat. The API team is proud to be collaborating with Microbix and our clinical lab customers to initiate a PT program that fulfills this urgent need."

Cameron Groome, chief executive officer and president of Microbix, also commented: "We're pleased to create the QAPs that enable this vital API PT program to determine which MDx tests will or won't detect H5N1 flu. Whether it is classical techniques or cutting-edge synthetic biology, Microbix is fully staffed and equipped to safely create and manufacture such critically needed test control products for use around the world."

Clinical labs can request to enroll in this API pilot PT program by reaching out to TechSupport@api-pt.com and enquiries about Microbix QAPs can be directed to customer.service@microbix.com.

About Microbix Biosystems Inc.

Microbix Biosystems creates proprietary biological products for human health, with over 100 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. FDA (U.S. Food and Drug Administration) registered, Australian TGA (Therapeutic Goods Administration) registered and Health Canada establishment licensed and provides IVDR-compliant (In Vitro Diagnostic Regulation) CE-marked (Conformite Europeenne) products across the European Union.

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