Ms. Sarah Sokol reports
MICROBIX QUALITY PRODUCTS ATTAIN EUROPEAN REGISTRATION
Microbix Biosystems Inc. has received 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 (human papillomavirus) 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 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 in the Netherlands (Oct. 9 to 11, 2019) and the MEDICA Trade Fair in Germany (Nov. 18 to 21, 2019).
Cameron Groome, chief executive officer 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.
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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