Innovative “EQA” Program to Qualify Labs for Genital Ulcer Disease Testing
MISSISSAUGA, CANADA & HELSINKI, FINLAND – June 20, 2023 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter and Labquality Oy (Labquality), a global provider of laboratory external quality assessment (“EQA”) programs, announce their creation of 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&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 9 countries. In the EQA rounds performed thus far, the Microbix “PTDx™FLOQ® – HVT” QAPs were detected by 97% 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) via R-Biopharm Clinical Canada at firstname.lastname@example.org, international labs via their local Labquality distributor or email@example.com, and enquires about Microbix QAPs can be directed to firstname.lastname@example.org.
About Labquality Oy, a part of COR Group Oy
Based in Helsinki, Labquality is a Finnish owned and operated life sciences company that provides clinical laboratories with external quality assessment (EQA) programs to evaluate their proficiency and attain necessary accreditations. Labquality services approximately 8,000 customers in over 60 countries and maintains an extensive network of sub-distributors to support its products and programs.
About Microbix Biosystems Inc.
Microbix Biosystems Inc. creates proprietary biological products for human health, with over 100 skilled employees and annualized sales targeting C$ 2.0 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 & 13485 accredited, U.S. FDA registered, Australian TGA 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. Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada.
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of GUD, the EQA program, Labquality, Copan, or their relevance, Microbix’s products or services, business and business results, goals or outlook, risks associated with financial results and stability, development projects such as those referenced in its presentations, regulatory compliance and approvals, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity or timeliness of delivery), currency exchange rates, maintaining adequate working capital or raising new capital on acceptable terms or at all, and other similar statements about anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions, and expectations; they are not guarantees of future performance. Microbix cautions that all forward-looking information is inherently uncertain and actual performance may be affected by a number of material factors, many of which are beyond its control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions, and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent Microbix’s judgement as of the date of this new release, and it is under no obligation to update or alter any forward-looking information.
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Microbix®, DxTM™, Kinlytic®, PTDx™, and QAPs™ are trademarks of Microbix Biosystems Inc.
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