Microbix & SpeeDx Form Exclusive Collaboration
MISSISSAUGA, CANADA and EVELEIGH, AUSTRALIA April 26, 2021 – Microbix Biosystems Inc. (TSX: MBX, OTCQB: MBXBF, Microbix®), a life sciences innovator and exporter, and SpeeDx Pty. Ltd. (SpeedDx), a developer of innovative molecular diagnostics solutions, are pleased to announce the formation of a collaboration under which Microbix will be exclusive developer of Quality Assessment Products (QAPs™) to facilitate the registration and commercialization of SpeeDx diagnostic assays.
The collaboration will begin with support of SpeeDx’s diagnostic tests for infection with antimicrobial-resistant (AMR) strains of Mycoplasma genitalium (AMR MGEN), a widespread sexually-transmitted infection and a test market expected to exceed US$ 1.0B globally by 2027. AMR MGEN is known to have multiple mutations that render certain antibiotics ineffective against it. Accurate diagnosis of such drug-resistant infections requires control materials sensitive to these mutations – in order to confirm the test performance. However, producing AMR MGEN controls in commercially-relevant quantities has posed technical hurdles that have been solved using proprietary Microbix technology. This is enabling Microbix to produce the QAPs required by SpeeDx to complete development and registration of its AMR MGEN assays. This same Microbix technology can be used to safely produce a range of QAPs to support tests for other AMR and XDR (extremely drug-resistant) organisms.
Microbix and SpeeDx believe it is pointless or harmful to prescribe anti-microbials to which an infection is resistant. Most current diagnostic tests cannot detect any drug-resistance mutations. The new generation of diagnostics being developed by SpeeDx detect the mutations that drive resistance, enabling more effective treatment. In turn, Microbix has established how to create QAPs for AMR or XDR versions of bacteria and viruses – safely, economically, and in large quantities. Such Microbix biomaterials will be used by SpeeDx to finalize the development, regulatory filings and commercialization of a range of its diagnostic tests, as they continue to provide products and services in partnership with some of the world’s largest diagnostics-makers and clinical labs.
Phil Casselli, SVP of Business Development at Microbix, remarked, “AMR and XDR infections are a dangerous evolution that are leading to challenges in infection control and treatment. We’re therefore very pleased to help SpeeDx to bring their extremely valuable new diagnostic tests to the market”.
Colin Denver, CEO of SpeeDx, commented, “SpeeDx is a world-leader in creating the next-generation assays needed to effectively diagnose and treat drug-resistant bacterial and viral infections. So it makes great sense to work with Microbix and apply its innovative and proprietary controls to ensure the best-possible accuracy of our tests. We believe this alliance will be of great benefit to healthcare globally.”
About Microbix Biosystems
Microbix develops proprietary biological technology solutions for human health and well-being, with about 90 skilled employees and sales growing from a base of over $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 30 countries, distributed by 1WA (Oneworld Accuracy Inc.), Alpha-Tec Systems, Inc., D.I.D. Diagnostic International Distribution SpA, Labquality Oy, The Medical Supply Company of Ireland Ltd, R-Biopharm AG, and Seegene Canada Inc. 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 viral transport medium (DxTM™) to stabilize patient samples for lab-based molecular diagnostic testing and Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots. Microbix is traded on the TSX and OTCQB, and headquartered in Mississauga, Ontario, Canada.
Founded in 2009, SpeeDx is an Australian private company with subsidiaries or distributors in the EU, UK, and US. SpeeDx specializes in molecular diagnostics that provide for improved patient management. Its real-time (qPCR) innovations drive market-leading multi-pathogen tests, and a portfolio focused on such “multiplex” diagnostics for sexually-transmitted infection, drug-resistance, and respiratory disease. For more, visit https://plexpcr.com.