Mr. Pavel Zhelev reports

MICROBIX & LABQUALITY CREATE NOVEL TESTING ACCREDITATION PROGRAM

Microbix Biosystems Inc. and Labquality Oy, a global provider of laboratory external quality assessment (EQA) programs, have created the world's first program to support accreditation of clinical laboratories for detecting the pathogens most commonly causing genital ulcer disease (GUD).

This novel Labquality EQA program will help ensure the proficiency of clinical labs testing to diagnose the pathogens that cause GUD. Initially, the program ascertains lab competency in detecting the four pathogens that are the most common causes of GUD -- the organisms of herpes simplex 1 and 2 (HSV 1 and 2), varicella zoster (VZV/chicken pox), and Treponema pallidum (TP/syphilis). As the clinical presentation of these infections can be similar, testing distinguishes between them to better direct treatment decisions. Other GUD pathogens, such as mpox (monkeypox), can be added to the program as needed.

A Microbix fourplex quality assessment product (QAP), formatted onto a Copan FLOQSwab, is used to establish the proficiency and accuracy of the GUD testing. In turn, Labquality has designed and is managing this GUD-oriented EQA program -- which is now offered to labs in 60 countries.

The QAPs and EQA program were validated by way of a pilot study that involved 18 clinical laboratories in nine countries. In the EQA rounds performed thus far, the Microbix PTDx FLOQ -- HVT QAPs were detected by 97 per cent of the participants using tests across different instrument/assay platforms. Full results will be presented by Labquality or Microbix at an appropriate industry forum over the coming months.

Juha Wahlstedt, sales director at Labquality, commented: "We're pleased to be employing Microbix's innovative QAPs for this new and important EQA program. Genital ulcers are the cause of a considerable and growing burden of disease that can only be alleviated by way of accurate diagnosis and treatment."

Pavel Zhelev, director of project management at Microbix, also commented: "We're pleased to enable the creation of EQA for these clinically important diseases. Our expertise was joined to that of Labquality and Copan to ensure accurate testing and properly directed treatment is widely available for GUD patients."

Canadian labs can enroll in this GUD EQA program (product code 5556) through R-Biopharm Clinical Canada at orders@r-biopharm.ca, international labs through their local Labquality distributor or info@labquality.fi, and enquires 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 annualized sales 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 EQA and 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, 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.

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