Four IVD Controls to Support Performance of Human Papilloma Virus (HPV) Tests
Mississauga, ON (GLOBE NEWSWIRE) - Microbix Biosystems Inc. (TSX: MBX, Microbix®), an innovator of biological products and technologies, is pleased to announce U.S. availability of 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 tens of millions of HPV tests already conducted annually in the United States and helping to enable greater usage of such testing.
Microbix has registered with the U.S. Food and Drug Administration (FDA) in compliance with Code of Federal Regulations 21, Part 807, thereby permitting the sale of its REDx™ HPV 16, 18 and 45 Positive Controls, and its REDx™ HPV Negative Control within the United States and its territories. 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. U.S. marketing will be directed to the 34,000 clinical laboratories certified or accredited under the U.S. “CLIA” regulations. Microbix expects to sell directly to the largest chains of labs, with support from distributors for other lab customers. Microbix will be represented at two upcoming industry events – the European Meeting on Molecular Diagnostics (EMMD) in the Netherlands (October 9 to 11, 2019), and the MEDICA Trade Fair in Germany (November 18 to 21, 2019).
Microbix is a leading white-label provider of materials that support the proficiency testing (PT) programs of laboratory accreditation organizations. In 2018, its offerings were extended to support the validation, verification and training objectives of test and instrument makers, with its branded PROCEEDx™ product line. ISO 13485 quality certification and the registration of innovative IVD controls for use by clinical laboratories is further broadening its market access, with such products offered under its REDx™ Controls trade name. All Microbix’s quality assessment products (QAPs™, including its EQA/PT products, PROCEEDx™ line, and REDx™ Controls line) 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.
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 U.S. registration or regulatory compliance, HPV and its quality products, the outlook for the business or its markets, 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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