Four IVD Controls to Support Performance of Human Papilloma Virus (HPV) Tests
MISSISSAUGA, September 5, 2019 – Microbix Biosystems Inc. (TSX: MBX, Microbix®), an innovator of biological products and technologies, is pleased to announce European registration for four innovative in-vitro diagnostic (IVD) control products for evaluating performance, procedures, and workflow of laboratory tests that detect and type HPV nucleic acids (DNA or RNA) in various human tissue samples.
HPV is a family of more than 100 closely-related viruses, commonly described as “types,” of which one or more are carried by most sexually-active adults. Over a dozen HPV types have been linked to development of cancers and are therefore classified as high-risk. Infections with high-risk HPV types are leading causes of cervical, penile, anal, oral, and throat cancers. Cervical cancer screening has historically relied on pathology-based testing (i.e., the “PAP” test), but no such program exists for other HPV-driven cancers. Additionally, reliance on the newer technology of nucleic acid (NA) HPV testing is hampered by a lack of fully-adequate sample controls to help ensure accurate positive or negative test results. Microbix’s IVD control products aim to address that need by supporting the millions of NA HPV tests already conducted annually in European countries and helping to enable greater usage of such testing.
Microbix has secured “CE Mark” registration in compliance with European Council Directive 98/79/EC, permitting the sale of its REDx HPV 16, 18 and 45 Positive Controls, and its REDx HPV Negative Control within the member states of the European Economic Area. Going forward, Microbix intends to broaden its IVD REDx Controls line to include additional high-risk HPV types, as well as other species of pathogens.
These Microbix REDx Controls will address the quality systems needs of clinical laboratories conducting NA testing for HPV typing. Initial European sales efforts will be directed to the many clinical laboratories in France, Germany, Italy, and the United Kingdom. Microbix expects to sell directly to the largest chains of labs, with support from national distributors for other customers. Microbix will be represented at two upcoming industry events in Europe – the European Meeting on Molecular Diagnostics (EMMD) in the Netherlands (October 9-11, 2019), and the MEDICA Trade Fair in Germany (November 18-21, 2019).
Cameron Groome, CEO and President, commented on this registration, “Our team has created excellent controls to support molecular HPV tests, with these novel and branded REDx Controls products demonstrated to work when used with the leading diagnostic instrument platforms. We are therefore very pleased to be able to release these clinically-important products to laboratory customers across Europe.”
All Microbix’s quality assessment products (including its EQA/PT products, PROCEEDx™ line for validation, verification and training, and REDx™ Controls) are listed on the company website at www.microbix.com.
About Microbix Biosystems
Microbix specializes in developing proprietary biological and technology solutions for human health and well-being. It manufactures a wide range of critical biological materials for the global diagnostics industry, notably its antigens for use in immunoassays and its quality assessment products (QAPs™). Microbix’s products are sold to more than 100 customers worldwide, primarily to multinational diagnostics companies and laboratory accreditation organizations.
Microbix also applies its biological expertise and infrastructure to create proprietary new products and technologies. Currently it has two; (1) Kinlytic® urokinase, a biologic thrombolytic drug (used to dissolve blood clots) and (2) LumiSort™ cell-sorting, a technology platform for ultra-rapid and efficient sorting of cells or other particles. Established in 1988, Microbix is a publicly traded company, listed on the Toronto Stock Exchange and headquartered in Mississauga, Ontario, Canada.
Contact Information for Laboratory and Distributor Enquiries
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This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, management’s discussion of its CE Mark registration or regulatory compliance, HPV and its quality products, the outlook for the business, the risks associated with its financial results and stability, its technologies or their expected benefits, actions of its customers, its antigens and quality products businesses, development projects such as those referenced herein, operations in foreign jurisdictions, engineering and construction generally, production (including control over costs, quality, quantity and timeliness of delivery of products), 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:
Cameron L. Groome, CEO
Jim Currie, CFO
Deborah Honig, Investor Relations – Adelaide Capital Markets