Microbix Presents HCV FLOQSwab® Format Test Control at ADLM

Driven by Fingerstick Blood and Room-Temperature Stable for POCTs


MISSISSAUGA, Canada, July 25, 2024 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces that it is presenting results of a novel Quality Assessment Product (“QAP™”) for supporting Point-of-Care-Tests (“POCTs”) for infection with the Hepatitis C Virus (“HCV”) at the American Diagnostic and Laboratory Medicine (“ADLM”) conference taking place in Chicago, Illinois July 29 to August 1, 2024.

At ADLM, Microbix will exhibit alongside leading firms that provide tests to diagnose and direct treatment of HCV and many 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 ADLM, Microbix will present its poster titled “Novel Hepatitis C Virus External Quality Control that is Stable at Ambient Temperature and Suitable for Use in Low-Resource Settings.” The poster reviews the performance of a novel PROCEED®FLOQ® (RUO) QAP to support the training for and prospective quality management of POCT PCR tests that use fingerstick whole-blood samples to detect HCV. Following presentation of the poster on the afternoon of July 30, it will be made available at https://microbix.com.

In spite of efforts to eliminate viral hepatitis, it is estimated that 58 million individuals are infected with HCV. The majority of such persons live where conventional lab-based diagnostics are inaccessible due to high costs, want of equipment or trained personnel, or lack of “cold-chain” refrigeration. HCV POCTs are therefore critical for improving test accessibility, surveillance, and treatment, with such POCTs requiring suitably designed and robust External Quality Controls (e.g., QAPs) to monitor the accuracy of testing.

The novel Microbix HCV QAP is formatted onto a COPAN® FLOQSwab® to help achieve a consistent and accurate signal, provide room-temperature stability, and be superior to conventional HCV quality controls that must be kept frozen until use. The QAP is also whole-genome to contain all relevant PCR-test targets, works with the relevant sample-elution reagents, and has long-term stability at ambient temperatures (i.e., 2 to 30 ºC). This QAP is intended to facilitate and accelerate the rollout and adoption of POCTs for HCV, particularly for geographically or culturally-isolated persons and in low or middle-income countries.

Amer Alagic, Microbix’s Director of R&D and a co-author of the poster commented, “We believe this PROCEEDxFLOQ QAP is the first swab-based and room-temperature stable control for HCV POCTs. Our Microbix team is pleased to again be speeding-up the responsible rollout of tests for high-impact infectious diseases such as HCV and thereby reducing its individual and global health burden.”

Microbix gratefully acknowledges three external collaborators on this work, namely Flinders University (Australia), BioQControl (The Netherlands), and Cepheid Inc. (United States).

Purchase enquiries for 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 now targeting C$ 2.0 million per month. It makes and exports 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 ADLM, the Poster, the HCV 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,
CFO
(905) 361-8910
Deborah Honig,
Investor Relations
Adelaide Capital Markets
(647) 203-8793
ir@microbix.com

Copyright © 2024 Microbix Biosystems Inc.
Microbix®, DxTM™, Kinlytic®, PROCEEDx®, and QAPs™ 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.
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