Ms. Sydney Rivers reports

MICROBIX ASSISTING EMQN WITH SECOND GENETIC-TEST EQA PROGRAM

Microbix Biosystems Inc. and EMQN CIC have arranged a go-live program to support rapid and accurate identification of patients who carry gene-variants associated with faster and slower than normal metabolism of the widely prescribed antiplatelet (anti-clotting) drug Clopidogrel (brand named Plavix).

This novel EQA program is to help ensure the proficiency of sites performing point-of-care tests (POCTs) that detect if patients carry any of three clinically-relevant variants of the Cytochrome P450 CYP2C19 liver enzyme gene (that is, two-times or three-times loss of function, or 17-times enhanced function). Over 20 per cent of persons carry these gene variants that can lead to overdosing or underdosing. Patients with genes relating to slower metabolic clearance can be overdosed, increasing the risk of life-threatening internal bleeding. In turn, those genes relating to faster metabolic clearance can be underdosed, reducing effectiveness and putting them at risk of life-threatening blood clots. As treatment decisions must often be made rapidly, POCT-based genotyping is critical to guide appropriate antiplatelet dosing in a time-sensitive clinical window.

Antiplatelet drugs are commonly prescribed to persons deemed at risk of heart attack, stroke, pulmonary embolism, deep vein thrombosis, peripheral arterial occlusions or atrial fibrillation. It is estimated that over 15 million prescriptions for Clopidogrel are written in the United States each year. All such patients in the United States, United Kingdom, Canada and globally can benefit from pharmacogenomic POCTs to assess their rate of drug metabolism -- to reduce their risk of harm as a result of excessive or inadequate drug therapy.

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 genetic testing. With a subscription to this EMQN EQA scheme, 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 help physicians and pharmacists make safe and effective prescription decisions.

Sean Sales, operations director at EMQN, commented: "It's been a pleasure to have Microbix's assistance in making QAPs for this groundbreaking and important new POCT EQA program. Physicians and pharmacists need information to be able to rapidly evaluate the risk-benefit of antiplatelet treatments, and no patient should be put at risk of life-threatening bleeding or clots due to inappropriate dosing."

Sydney Rivers, product manager at Microbix, also commented: "We're pleased to help create EQA for this clinically important testing. Our expertise joins that of EMQN and Copan to ensure optimal treatment is available for patients worldwide. These QAPs are Microbix's second entry into supporting the accuracy of genetic tests, adding to our established presence in infectious diseases and emerging role in oncology."

U.K. and international labs can enroll in this EQA program (code POCT CYP2C19) via EMQN CIC at the company's website and enquiries about Microbix QAPs can be directed to customer.service@microbix.com.

About Microbix Biosystems Inc.

Microbix creates proprietary biological products for human health, with over 120 skilled employees and revenues targeting $2.0-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) and reference materials (QUANTDx) supporting POCT and clinical lab EQA, enabling assay development and validation, or helping ensure the quality of clinical diagnostic workflows. Its antigens drive the tests of approximately 100 diagnostics makers, while QAPs or QUANTDx 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, United States Food and Drug Administration-registered, Australian TGA-registered, Health Canada-establishment-licensed, and provides IVDR-compliant CE-marked products.

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