Mr. Cameron Groome reports
MICROBIX QUALITY PRODUCTS ENTER U.S. MARKET
Microbix Biosystems Inc. has made available in the United States 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 (that is, 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 (Oct. 9 to Oct. 11, 2019), and the MEDICA Trade Fair in Germany (Nov. 18 to Nov. 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 are 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.
About Microbix Biosystems Inc.
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. 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.
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