Microbix Launches New STI-Related Quality Assessment Products
QAPs™ to Support Accuracy of Mgen Testing Workflows
MISSISSAUGA, CANADA, October 15, 2020 - Microbix Biosystems Inc. (TSX: MBX, OTCQB: MBXBF, Microbix®), a life sciences innovator and exporter, announces its creation, external verification, and registration of new quality assessment products (QAPs™) to help ensure the accuracy of workflows at labs conducting nucleic acid testing for sexually-transmitted Mycoplasma genitalium (Mgen) infections.
Mgen is a small bacteria that causes widespread and persistent infection of the urinary and reproductive tracts in men and women. Mgen infections impact as many as one-in-five sexually-active adults, are a frequent cause of urethral or reproductive tract inflammation, and a cause of infertility. Mgen infections can be treated with antibiotic therapy, although drug-resistant strains are a growing problem.
In spite of its relative ubiquity, testing for Mgen is not widespread. This has been largely due to very limited availability of validated control materials to help ensure the accuracy and reliability of nucleic acid tests for Mgen infections. Mgen is notoriously difficult to culture ex-vivo, making it extremely challenging to create adequate quantities of test workflow quality control materials. Microbix has overcome this challenge and can now supply quantities sufficient to meet expected commercial demand.
Using its expertise and that of collaborators, Microbix has created and is now launching whole-genome and whole-process QAPS for nucleic acid Mgen tests, branded as REDx® Mycoplasma genitalium positive or negative controls and available in a refrigeration-stable liquid vial format. These new Mgen QAPs have achieved their “CE mark” to permit sale across the EU, have been added under Microbix’s U.S. FDA establishment registration, and are targeted to become available in Australia and Canada.
Microbix has created its Mgen QAPs to support laboratory proficiency testing and accreditation, test development or lab training, and clinical lab workflows. External validation of these products has been completed with multiple well-recognized makers of nucleic acid tests for Mgen infections and multiple international laboratory proficiency testing and accreditation organizations.
As for all Microbix’s QAPs, the Mgen-test variants are designed to provide support for quality management systems regardless of what specific tests are in use and additional to whatever on-board controls are used within particular tests. As such they supplement accuracy without risk to patients. Ordering enquiries should be directed to Microbix or its distributors: Alpha-Tec Systems, Inc., Diagnostic International Distribution S.p.A., Labquality Oy, The Medical Supply Company of Ireland, and R-Biopharm AG.
Microbix believes these Mgen products are complimentary to its QAPs for high-risk variants of Human Papilloma Virus (HPV). With Mgen and HPV QAPs (that support testing workflows for HPV types 16, 18 and 45), Microbix has a growing line of products to support testing for sexually-transmitted infections. Microbix remains committed to continuing to build its portfolio of innovative, proprietary, and branded QAPs – currently focused within the respiratory and sexually-transmitted segments of infectious disease.
About Microbix Biosystems
Microbix develops proprietary biological and technology solutions for human health and well-being, with about 80 skilled employees and sales of approximately $1 million per month. It makes a wide range of critical biological materials 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. Microbix antigens enable the antibody tests of over 100 international diagnostics companies, while its QAPs are sold to clinical laboratory accreditation organizations, diagnostics companies, and clinical laboratories. Microbix QAPs are now available in over 20 countries, distributed by Alpha-Tec Systems, Inc., Diagnostic International Distribution S.p.A., Labquality Oy, The Medical Supply Company of Ireland, and R-Biopharm AG. Microbix is ISO 9001 and 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. Microbix is publicly-traded on the TSX and OTCQB, and headquartered in Mississauga, Ontario, Canada.
