Reporting on Test-Workflow Controls for Important Sexually-Transmitted Infections

MISSISSAUGA, CANADA, December 15, 2020 – Microbix Biosystems Inc. (TSX: MBX, OTCQB: MBXBF, Microbix®), a life sciences innovator and exporter, announces it has been invited to present about the performance of two types of its test-workflow Quality Assessment Products (QAPs™) at the 2020 virtual Scientific Meeting and Clinical Lab Expo of the American Association of Clinical Chemistry (AACC) taking place December 13-17, 2020.

The first abstract presentation is titled “Novel Mycoplasma genitalium (Mgen) and AMR Mgen A2059G Materials for use in a Cross-Platform NAAT Quality Control.” It reviews performance of novel, innovative, & proprietary REDx™ (IVD) Mgen positive controls, and PROCEEDx™ (RUO) Mgen A2059G positive samples.

The abstract demonstrates the performance of Microbix’s Mgen and antimicrobial-resistant (AMR) Mgen quality assessment products (QAPs™), designed for use across multiple commercially-available nucleic acid amplification testing (NAAT) platforms. Mgen NAAT is emerging as a cornerstone triage method for evaluation of this sexually-transmitted infection (STI). Furthermore, due to AMR Mgen, enhanced NAAT is needed and becoming mandatory in certain geographies. Currently, available NAAT is limited by a lack of Mgen quality control materials, resulting in inadequate patient testing and diagnosis. Microbix’s Mgen QAPs are intended to remove this limitation to NAAT for Mgen and AMR Mgen infections.

Microbix’s second abstract presentation is titled “Novel Cross-Platform High-Risk (HR) Low-Occurrence (LO) HPV NAAT Positive Samples for Use in Nucleic Acid Detection as Prospective Quality Control.” It reviews the performance of Microbix’s latest QAPs for support of NAAT workflows relating to detection of infections with high-risk types of the Human Papilloma Virus (HPV), a group of cancer-causing STIs.

Specifically, the second abstract describes the performance of new QAPs relating to high-risk HPV types 31, 33, and 39, and low-risk HPV type 67. Like all Microbix QAPs, these are full-genome test-workflow controls designed for compatibility across multiple NAAT platforms. HPV genotyping NAAT is now the preferred method for stratifying risk of cancer in infected patients. Moreover, population monitoring for the HR-LO HPV types is becoming routine to determine vaccination efficacy and viral type oncogenicity. However, lack of adequate QC material is slowing transition to such improved test methods. These new Microbix’s HPV QAPs should help remove this limitation and will be added to its current HPV line, which now provides RUO and IVD QAPs addressing viral types 16, 18, and 45, including a negative sample control.

The abstracts were authored by members of Microbix’s scientific and executive leadership, namely Mr. Pavel Zhelev, Dr. Amer Alagic, Ms. Jieran Li, Dr. Asieh Rasoolizadeh, Mr. Shane Niyamuddin, Dr. Mark Luscher, and Dr. Ken Hughes. Microbix thanks the authors, our broader team, and our many diagnostics industry collaborators for making these important contributions to human wellbeing, NAAT accuracy, and scientific knowledge. Both abstracts are being posted to Microbix’s website at

About Microbix Biosystems

Microbix develops proprietary biological and technology solutions for human health and well-being, with about 80 skilled employees and sales growing from a base of approximately $1 million per month. It makes a wide range of critical biological materials 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. Microbix antigens enable the antibody tests of over 100 international diagnostics companies, while its QAPs are sold to clinical laboratory accreditation organizations, diagnostics companies, and clinical laboratories. Microbix QAPs are now available in over 20 countries, distributed by Alpha-Tec Systems, Inc., Diagnostic International Distribution S.p.A., Labquality Oy, The Medical Supply Company of Ireland, and R-Biopharm AG. Microbix is ISO 9001 and 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 media 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 OTCQB, 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, all discussion regarding AACC or the content or meaning of the abstract presentations, Microbix’s business and business results, goals or outlook, risks associated with financial results and stability, development projects such as those referenced in its corporate presentation, regulatory compliance and approvals, sales to domestic or foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity and timeliness of delivery), foreign currency and exchange rates, maintaining adequate working capital and raising further capital on acceptable terms or at all, and other similar statements concerning 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. The Company cautions that all forward looking information is inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s 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 the Company’s judgement as of the date of this new release, and the Company is under no obligation to update or alter any forward-looking information.

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For further information, please contact Microbix at:

Cameron Groome, CEO

(905) 361-8910

Jim Currie, CFO

(905) 361-8910

Deborah Honig, Investor Relations

Adelaide Capital Markets

(647) 203-8793


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Microbix®, Kinlytic®, PROCEEDx™, QAPs™, and REDx™ are trademarks of Microbix Biosystems Inc.