Microbix & Aurevia Introduce Novel EQA Scheme

Pilot Program for Qualifying Clinical Labs to Diagnose Bacterial Vaginosis

MISSISSAUGA, Ontario and HELSINKI, Finland, May 13, 2025 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, and Aurevia Oy via its Labquality EQAS affiliate (Aurevia), announce a pilot external quality assessment (“EQA”) program to help clinical laboratories establish their proficiency at using molecular diagnostic methods (e.g., PCR tests) to diagnose bacterial vaginosis (“BV”).

BV is a common vaginal condition that will affect a large percentage of women during adulthood. BV is caused by an imbalance in the bacterial flora of the vagina, with non-beneficial species becoming dominant. BV has historically been diagnosed by changes in vaginal acidity, odor, or by microbiology – methods which are sometimes not definitive. In contrast, molecular diagnostic (“MDx”) tests can distinguish each of the organisms that should be present in vaginal flora and detect whether their proportions are normal. Accordingly, MDx tests for BV can provide definitive diagnoses and help determine a treatment plan.

The EQA program being introduced by Aurevia is number 5305, titled “Bacterial vaginosis and vaginitis multiplex nucleic acid detection.” The current pilot study is intended for clinical labs diagnosing BV, as well as other vaginal infections, such as vulvovaginal candidiasis and trichomoniasis. The program will be run with simulated samples made by Microbix (“QAPs™”). After completion of the pilot study and analysis of its results, it is anticipated that an ongoing program for BV will be added to the Aurevia Labquality EQAS portfolio of EQA schemes to which clinical laboratories testing for BV can subscribe.

Microbix QAPs are designed to fully emulate clinical specimens from patients while being safe and stable. For this BV pilot program, Microbix has created three QAPs samples formatted onto Copan® FLOQSwabs® – to correctly emulate the workflow of MDx tests for BV from collection of patient specimens through to the reporting of test results. Each of the three QAPs is non-infectious and, as for Microbix’s full portfolio of PROCEEDx®FLOQ® and REDx®FLOQ® QAPs, is stable at room temperature for at least two years.

Heidi Berghäll, EQA Solutions Manager, R&D of Aurevia, commented, “It is important that emerging MDx tests for the diagnosis of BV are properly validated. With a proper EQA scheme to monitor labs’ ongoing performance, such tests should improve access to care, ensure timely and accurate diagnosis, and help determine curative treatment. Aurevia is proud to be addressing these important clinical needs.”

Cameron Groome, CEO & President of Microbix, also commented, “It is a pleasure to work with global leaders like Aurevia to validate complex next-generation diagnostic tests, such as MDx tests for BV. Our objective is to be the leading partner for PT/EQA providers, test-makers, and clinical labs for providing QAPs to help ensure that their testing attains and sustains the highest possible levels of accuracy and quality assurance.”

Enquiries about Microbix QAPs can be e-mailed to customer.service@microbix.com.

Enquiries about Aurevia, or the BV EQA Scheme can be emailed to info@aurevia.com

About Microbix Biosystems Inc.
Microbix Biosystems Inc. creates proprietary biological products for human health, with over 120 skilled employees and sales now targeting C$ 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™) 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 & 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides IVDR-compliant CE marked products.

Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots, and reagents or media to support molecular diagnostic testing (e.g., its DxTM® for patient-sample collection). Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada.

About Aurevia OY
As Aurevians, we are the excellence makers: a team of experienced experts in healthcare and health-tech standards and quality. Together, we advance healthcare, pharmaceutical and medical technology development with a future-focused approach, aligned with client needs. Driven by our commitment to care, we contribute quality to the industry and pave the way for safer, more effective patient care worldwide.

We are a full-service, rapid-response External Quality Assessment Services (EQAS) provider and Contract Research Organization (CRO). Our quality services for the healthcare, pharmaceutical, and medical technology industries cover external quality assessments, quality assurance, regulatory affairs, clinical investigations and trials, audits and certifications, and training. Our expertise and knowledge benefit medical device and in vitro diagnostic manufacturers, pharmaceutical companies, healthcare units, and clinical laboratories. Currently, we serve over 8,000 EQA customers in over 60 countries around the world. Our team comprises nearly 200 skilled professionals in Finland, Sweden, Poland, and Germany. Supported by Mérieux Equity Partners, Aurevia empowers clients with excellence-driven solutions to achieve the highest standards in patient care.

Forward-Looking Information
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of Aurevia, BV and testing, the EQA pilot program, the QAPs, 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, access to and 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 many material factors, any number 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.

Please visit https://microbix.com or https://sedarplus.ca for recent Microbix news and filings.

For further information, please contact Microbix at:

Copyright © 2025 Microbix Biosystems Inc.
Microbix®, DxTM®, Kinlytic®, PROCEEDx®, QAPs™, and REDx® are trademarks of Microbix Biosystems Inc.
PROCEEDx®FLOQ® and REDx®FLOQ® are trademarks of Microbix in collaboration with Copan Italia S.p.A.
COPAN®, FLOQ®, and FLOQSwab® are trademarks of Copan Italia S.p.A.
Other companies’ names may be protected by their own respective trademarks

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