FLOQSwab-formatted QAPs Supporting Fourplex PCR Tests for Bacterial STIs

MISSISSAUGA, CANADA, July 24, 2023 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces that it is presenting results of its Quality Assessment Products (“QAPs™”) for supporting the clinical use and accuracy of multiplex tests for four of the most prevalent sexually-transmitted infections (“STIs”) at the American Association of Clinical Chemistry (“AACC”) conference  taking place in Anaheim, California July 23 to 27, 2023.

At AACC, Microbix will exhibit alongside leading firms that provide tests to diagnose and direct treatment of STIs and other infectious diseases. Microbix will thereby showcase its ever-growing portfolio of QAPs that help ensure the accuracy of antigen and molecular (i.e., “PCR”) tests and their workflows.

Also at AACC, Microbix will present a poster titled “Evaluating the Performance of Emerging STI Point of Care Assays Using Novel, Room Temperature Stable CT/NG/TV/MG Positive Swab Quality Control Materials.” The poster reviews the performance of novel PROCEED®FLOQ® (RUO) QAPs to support the clinical use and accuracy of multiplex PCR tests for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG) – four of the most prevalent STIs. The poster can be read at https://microbix.com and a REDx®FLOQ® (IVD) product format is also available.

Point of Care Tests (“PoCTs”) that can distinguish between STI-causing pathogens promise improved access to care and faster turnaround time from patient-sampling to test-result. However, users of such PoCTs must have accurate and robust test-control materials for quality management purposes. Microbix therefore developed a whole-workflow multiplex STI QAP desiccated on a Copan FLOQSwab® that is stable at 2-30°C and contains inactive whole-genome target pathogens. The poster evaluated its performance with multiple diagnostic platforms in current use and in development, namely the Abbott Alinity™ m STI assay, Aprimeo/Bosch Vivalytic™ STI Assay, BD MAX™ CT/GC/TV assay, Cepheid Xpert® CT/NG and TV assays, Seegene Novaplex™ CT/NG/TV/MG assay, an IVD assay in late-stage development, and a lab-developed assay.

Dr. Amer Alagic, an author of the poster and Director of R&D at Microbix, commented prior to his presentation of the poster at AACC “Microbix’s whole-genome and room-temperature stable FLOQSwab-formatted QAPs continue to demonstrate their ability to support quality management on a wide range of molecular assays and instrument platforms. We’re pleased to be offering Microbix QAPs to support clinically-important STI testing – as tools for validation, verification, and training, as external quality assessment samples, and as in-kit controls.”

Purchase enquires for these and all 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 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 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.

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 AACC, the Poster, the STI 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 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.

Please visit https://microbix.com or www.sedar.com for recent Microbix news and filings.

For further information, please contact Microbix at:

Cameron Groome, CEO
(905) 361-8910
Jim Currie,
(905) 361-8910
Deborah Honig,
Investor Relations
Adelaide Capital Markets(647) 203-8793 ir@microbix.com

Copyright © 2023 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 Biosystems Inc. in collaboration with Copan Italia S.p.A.
Copan®, FLOQ®, and FLOQSwab® are trademarks of Copan Italia S.p.A.
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