FLOQSwab-formatted QAPs supporting PCR Tests for Antibiotic-Resistant Pathogens

MISSISSAUGA, CANADA, June 13, 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 tests for antimicrobial-resistant (“AMR”) sexually-transmitted infections (“STIs”) at the ASM Microbe conference of the American Society of Microbiology (“ASM”) , taking place in Houston, Texas June 15-19, 2023.

At ASM Microbe, 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 nucleic acid (i.e., “PCR”) tests and their workflows.

Also at the conference Microbix will present a poster titled “Evaluating the Performance of Nucleic Acid Amplification Tests that Detect Mycoplasma genitalium and Mutations Associated with Macrolide Resistance Using Novel Quality Controls Formatted on Swabs.” The poster reviews the performance of novel REDx®FLOQ® (IVD) and PROCEEDx™FLOQ® (RUO) QAPs to support the clinical use and accuracy of tests for AMR variants of the STI Mycoplasma gentialium (“Mgen”), a common cause of urethritis, cervicitis, pelvic inflammatory disease, and infertility. The poster will be made available at https://microbix.com.

As is becoming increasingly common with many infections, the emergence of AMR variants of Mgen is leading to a high rate of first-line treatment failure (i.e., 44-90%). If accuracy can be ensured, PCR-based testing can greatly improve treatment outcomes, but quality-control materials to support such tests were largely unavailable. Using innovative and proprietary methods, Microbix created and manufactured such materials – including for five AMR variants of Mgen. Formatted onto COPAN® FLOQSwabs®, the resulting Microbix QAPs were then used to validate and support novel tests for AMR detection, namely the SpeeDx Pty. Ltd. ResistancePlus® MG and the Seegene Inc. Allplex™ MG & AziR Assay.

Ms. Sydney Rivers, lead author of the poster and Product Manager at Microbix, commented “Microbix’s whole-genome samples of antibiotic-resistant Mgen were successfully designed, manufactured, titrated, buffered, applied to FLOQSwabs, stabilized, and dried. The resulting room-temperature stable QAPs demonstrate that they support testing with varied advanced PCR-assay workflows and elution buffers. Microbix is therefore pleased to be offering flocked-swab formatted QAPs that support clinically-important AMR Mgen testing as cross-platform IVD quality controls, validation, verification, and training panels, and as external quality assessment samples.”

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 ASM Microbe, the Poster, the AMR 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 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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