Mr. Cameron Groome reports
MICROBIX ENGAGED TO DEVELOP & SUPPLY CUSTOM QAPS
Microbix Biosystems Inc. has been engaged to develop and supply custom quality assessment products (QAPs) to support the registration and sales of a new point-of-care instrument and its tests for viral respiratory pathogens.
Under an agreement between the parties, the companies' technical teams are collaborating to develop custom QAPs to support submission for U.S. FDA registration and waiver from U.S. "CLIA" regulations. The QAPs being developed will provide accompanying control kits for quality validations of multiple viral respiratory pathogen tests.
The customer instrument platform being supported by the custom Microbix QAPs is designed to be a simple, easy to use, portable point-of-care testing system with multiple advanced features. The instrument is intended for widespread deployment in pharmacies, doctors' offices, and other point-of-care locations, and to run a large menu of tests.
Microbix QAPs are designed to mimic actual patient samples, while being non-infectious, stable, and reliable. Under its PTDx, PROCEEDx, REDxFLOQ or REDx Controls brands, Microbix supplies a broad range of QAPs -- including but not limited to viral respiratory pathogens.
Microbix QAPs can provide support for the proficiency testing (PT) programs of lab accreditation organizations, instrument validation/verification and operator training, test development/registration, quality management systems of clinical laboratories, and point-of-care patient sample testing.
The agreement provides Microbix a series of payments for development services, followed by supply of minimum order quantities of the QAPs once developed. An initial non-refundable payment of US$ 45,000 has already been received by Microbix and the development portion of the agreement is expected to be completed in its fiscal 2020 (September 30). Purchase/supply of QAPs is expected to begin this fall and reach 100,000 units in the first year. First-year revenues from the agreement are expected to exceed CA$ 1.0 million.
Cameron Groome, CEO of Microbix commented, "Our deep experience in creating QAPs for international PT programs has built the expertise that enables us to create the custom controls necessary to support infectious disease tests on next-generation point-of-care instruments. We're pleased to have been selected by this customer for developing the QAPs needed to register their initial respiratory virus test menu and for QAPs supply upon their U.S. and international registrations."
About Microbix Biosystems
Microbix develops proprietary biological and technology solutions for human health and well-being, with approximately 80 skilled employees and sales now exceeding $1 million per month on average. 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 quality control of clinical diagnostic tests. 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 21 countries, distributed by 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, FDA and 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 a publicly-traded company, listed on the Toronto Stock Exchange and headquartered in Mississauga, Ontario, Canada.
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