Microbix Collaborator Introduces New Lab Accreditation Program

Microbix Product Supporting Testing for Drug-Resistant Sexually-Transmitted Infection

Mississauga, ON (GLOBE NEWSWIRE) - Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces that Labquality Ltd., a collaborator and customer, is presenting results of its use of Microbix Quality Assessment Products (“QAPs™”) for accreditation of clinical labs for conducting molecular (“MDx”) tests for antimicrobial-resistant (“AMR”) strains of M. genitalium (“Mgen”), a common sexually-transmitted infection (“STI”).

The poster presentation of results will be made at ECCMID 2024, the European Congress of Clinical Microbiology and Infectious Diseases taking place in Barcelona, Spain from April 27 to 30, 2024. The poster is titled “Mycoplasma genitalium, Drug Resistance, Nucleic Acid Detection; Introducing a New External Quality Assessment Scheme” and was authored by scientists from both Labquality and Microbix.

Mgen is a common STI in both men and women who have been sexually-active. Left untreated, Mgen is known to cause chronic health problems in women, such as chronic pain, ectopic pregnancy, infertility, and pelvic inflammatory disease, and non-gonococcal urethritis in men. As many as 50% of Mgen infections can be resistant to first-line antibiotic treatments. Tests for Mgen were not commonly conducted until the past several years, in part due to the unavailability of controls (e.g., QAPs) to assess and validate the accuracy of tests for antibiotic-susceptible and AMR strains of this bacteria.

As testing for Mgen and AMR Mgen infections becomes more widespread, external quality assessment (“EQA”) programs are needed to evaluate the proficiency of clinical labs and provide them accreditation to test patient-samples. The poster presents results of a Labquality program evaluating the proficiency of 38 clinical labs in their use of 16 different MDx assays (12 commercial & 4 lab-developed). Each clinical lab was evaluated for its ability to detect (i) Mgen, and (ii) an Mgen-related marker of resistance to macrolide antibiotics. It was found that (i) the Microbix Mgen QAPs (positives & negatives) were well-suited for this usage, (ii) the performance of labs and assays was excellent, (iii) specific reporting guidelines are needed to avoid errors, and (iv) there is a need for such an EQA program to support Mgen testing.

Microbix developed its Mgen QAPs to resemble patient specimens, support the whole testing process, and contain all possible MDx test targets – buffered and desiccated onto a Copan^® FLOQSwab^® to ensure multi-year product stability at room temperature. The pilot EQA program confirmed the performance of these QAPs across all clinical labs, instrument platforms, and assays. These Mgen QAPs are now available from Microbix as part of its PROCEEDx^®FLOQ^® (RUO) or REDx™FLOQ^® (IVD) catalogue of products.

Enquiries regarding the EQA program being developed by Labquality to qualify and support clinical laboratories in molecular testing for Mgen and AMR Mgen should be directed to Ms. Kati Luiro, EQA Coordinator, at kati.luiro@labquality.com, info@labquality.com, or via its website www.labquality.com. Purchase enquiries for these or other Microbix QAPs can be e-mailed to customer.service@microbix.com.

About Microbix Biosystems Inc.
Microbix Biosystems Inc. creates proprietary biological products for human health, with over 100 skilled employees and annualized revenues approaching C$ 2.0 million per month. It enables the worldwide commercialization of diagnostic assays by making 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 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.

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 Labquality or its EQA schemes, the Poster, the Mgen QAPs, or their relevance, Microbix’s or others’ 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 many material factors, some 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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