Microbix Partners with SEKISUI Diagnostics to Support COVID/Flu Tests
Executive Summary
- Microbix Biosystems announced that its external third‑party quality assessment products (REDx™ FLOQ® QAPs®) will be used to support SEKISUI Diagnostics’ U.S. commercialization of the Metrix® COVID/Flu molecular point‑of‑care assay.
- The partnership enables SEKISUI to offer a 20‑minute, three‑plex molecular test (detecting SARS‑CoV‑2, Influenza A and B) that has received Emergency Use Authorization from the U.S. FDA.
- Microbix will supply kits containing positive and negative QAPs, along with operator‑training materials, to ensure assay accuracy and compliance with U.S. IVD regulations.
Key Details
- Products Involved:
- REDx™ FLOQ® QAPs® (three‑plex positive QAP and a negative QAP) provided by Microbix.
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Metrix® COVID/Flu Test (20‑minute, three‑plex molecular assay) manufactured by Aptitude Medical Systems and distributed in the U.S. by SEKISUI Diagnostics under an exclusive agreement.
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Regulatory Status:
- The Metrix® COVID/Flu Test is authorized for emergency use by the U.S. Food and Drug Administration (EUA).
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Microbix’s QAP kits are supplied under full U.S. IVD compliance, with ISO 9001, ISO 13485, FDA registration, CE marking, and other relevant certifications.
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Commercial Arrangement:
- SEKISUI will incorporate the REDx™ FLOQ® QAPs into new Metrix installations to support operator training and quality control.
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Microbix’s role is limited to providing the QAP kits and associated training materials; no financial terms or revenue sharing disclosed.
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Strategic Rationale (Quotes):
- David Morris, Associate Director, Product Management, SEKISUI: Emphasized the importance of user‑training controls for successful market rollout.
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Phil Casselli, SVP of Sales & Business Development, Microbix: Highlighted meeting precise technical, practical, and regulatory requirements and ongoing support beyond launch.
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Company Context:
- Microbix reported FY2024 revenue of C$ 25.4 million and employs over 120 staff.
- The partnership expands Microbix’s QAP footprint into the U.S. point‑of‑care molecular diagnostics market, complementing its existing global distribution in >30 countries.
Notable Quotes
- “We’re very excited to be commercializing Metrix and its tests into the U.S. market… user training and providing these materials … is critical to our customer support.” – David Morris, SEKISUI Diagnostics
- “This project had precise technical, practical, regulatory requirements which we have fully met, and we will continue to support these valued clients through the launch of this assay and beyond.” – Phil Casselli, Microbix Biosystems
Materiality Assessment: Material – Positive (the announcement introduces a new revenue‑generating partnership supporting a FDA‑authorized diagnostic test in a large market).