Mr. Cameron Groome reports

MICROBIX ASSISTING EMQN WITH NOVEL GENETIC-TEST EQA PROGRAM

Microbix Biosystems Inc. and EMQN CIC, a global supplier of laboratory external quality assessment (EQA) schemes for human genomic testing, have rolled out a program to support the accurate identification of patients who carry a gene variant associated with increased susceptibility to hearing loss following treatment with a widely used class of antibiotics.

This first-of-its kind EQA program is intended to help ensure the proficiency of point-of-care testing (POCT) and acute-care labs that are assessing whether patients carry the MT-RNR1 m.1555A>G gene variant. It is estimated that one in 500 persons carry this variant that can lead to profound and irreversible hearing loss upon exposure to aminoglycoside antibiotics. This class of antibiotics include gentamycin, kanamycin, streptomycin and tobramycin, which are used to treat a wide range of gram-negative bacterial infections. Of particular concern are newborn babies who are suspected to be at risk of bacterial sepsis -- a life-threatening condition that can lead to death from multiorgan failure if not treated promptly with appropriate antibiotic drugs and other acute medical care.

Microbix-produced quality assessment products (QAPs), formatted onto Copan FLOQSwabs, are being used in this EMQN EQA program to help assess the proficiency and accuracy of such acute-care genetic testing. The QAPs provide samples that participants can process like cheek or buccal swabs, enabling them to verify the accuracy of MT-RNR1 assays in their POCT. With a subscription to this EMQN program, participants will receive three samples every two months (18 per year), helping them to ensure the accuracy of their testing on a continuing basis and thereby make the most reliable diagnoses possible.

Sean Sales, operations director at EMQN, commented: "It has been a pleasure to have Microbix's assistance in making the QAPs for this groundbreaking and important new EQA program. Acute-care physicians need the information to be able to evaluate the risk/benefit of antibiotic treatments and no patient should have to face a lifetime of hearing loss when tests to identify this risk are available."

Cameron Groome, chief executive officer and president at Microbix, also commented: "We're pleased to help enable the creation of EQA for this clinically important decision making. Our expertise was joined to that of EMQN and Copan to ensure that accurate testing and properly directed treatment is available for patients worldwide. This QAP marks Microbix's entry into supporting the accuracy of genetic tests, adding to our established presence in infectious diseases and emerging role in oncology."

United Kingdom and international labs can enroll in this EQA program (code POCT MT-RNR1 25) through EMQN's website and inquiries 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 markers, 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 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 Europeenne) products across the European Union.

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