Quality Control Materials for Genital Ulcer Disease Molecular Assays

MISSISSAUGA, CANADA, July 26, 2022 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces it is presenting about the utility of its multi-pathogen (“multiplex”) and swab-formatted Quality Assessment Products (“QAPs™”) to monitor molecular assays that detect and distinguish between four sexually-transmitted infections (each an “STI”) that cause Genital Ulcer Disease (“GUD”) – at the 2022 conference of the American Association of Clinical Chemistry (“AACC”) taking place in Chicago, Illinois from July 24-28, 2022.

Its poster presentation is titled “Novel Herpes Simplex Virus, Varicella Zoster Virus, and Treponema pallidum Quality Control Material for use with Genital Lesion Molecular Detection Assays.” The poster details the use of Microbix’s PROCEEDx™FLOQ® HSV1&2/VZV/Syphilis Swab Positive Sample QAPs to monitor the performance, procedures, and workflows of molecular assays that detect STIs from the oral and genital types of the Herpes Simplex Virus (“HSV 1” and “HSV2”), Varicella Zoster Virus (“VZV”) and Treponema pallidum (the spirochete bacteria causing “Syphilis”). The PROCEEDxFLOQ QAPs proved compatible with 13 molecular assays across both commercially-available diagnostic platforms and laboratory-developed tests, and were used to support an external quality assessment pilot study.

These assessments were coordinated by the Microbix team and consolidated data provided from 16 laboratories, notably including the Cadham Manitoba Provincial Laboratory (Winnipeg, Canada) and Labquality Ltd. (Helsinki, Finland), the support of which are gratefully acknowledged.

GUDs are a current and growing global health concern, with over 20 million new cases each year. Traditionally, diagnosis of GUD has relied on clinical assessment of symptoms, which lacks specificity given the similar appearance of ulcers caused by different etiological agents. Such non-specific diagnosis leads to misclassification, delayed treatment, and the development of complications. Although there is now a growing pipeline of molecular assays for sensitive and specific diagnosis of GUD, external quality control materials to verify performance have been largely unavailable. Microbix has overcome challenges in formulation and appears to be the first to develop a multiplex whole-workflow control for GUD assays. This STI-oriented PROCEEDxFLOQ multiplex QAP adds to Microbix’s expanding portfolio, which includes Health Canada, U.S. FDA, EU “CE mark,” or TGA (Australia) in-vitro-diagnostic (“IVD”) regulated REDx™ and research-use-only (“RUO”) PROCEEDx™ SKUs across both liquid-vial and Copan FLOQSwab® formats.

Further information about Microbix’s QAPs and its services offerings is available at https://microbix.com and purchase enquiries for QAPs™ can be e-mailed to customer.service@microbix.com.

About Microbix Biosystems

Microbix creates proprietary biological products for human health, with over 100 skilled employees and sales approaching 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 over 100 diagnostics makers, while QAPs are sold to clinical laboratory accreditation organizations, diagnostics companies, and clinical laboratories. Microbix QAPs are now available in over 30 countries, distributed by 1WA (Oneworld Accuracy Inc.), Alpha-Tec Systems, Inc., Diagnostic International Distribution SpA., Labquality Oy, The Medical Supply Company of Ireland, R-Biopharm AG, SDT Molecular Pte Ltd,  Seegene Canada Inc., and Thomas Scientific LLC. 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 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 or its relevance, the products of Microbix or its collaborators, 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 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 or 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.

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, CFO (905) 361-8910

Deborah Honig, Investor Relations Adelaide Capital Markets (647) 203-8793 ir@microbix.com

Jim Macdonald, Investor Relations Torrey Hills Capital (858) 456-7300 jm@sdthc.com

Copyright © 2022 Microbix Biosystems Inc.     

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

PROCEEDx™FLOQ® is a trademark of Microbix Biosystems Inc. in collaboration with Copan Italia S.p.A.

Copan®, FLOQ®, and FLOQSwab® are trademarks of Copan Italia S.p.A.