Microbix Engaged to Develop & Supply Custom QAPs

Instrument-Specific Controls to Support Rapid Tests for Viral Respiratory Pathogens

MISSISSAUGA, Ontario, June 01, 2020 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, Microbix), an award-winning life sciences innovator and exporter, announces that it 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.