Microbix aids Sekisui Covid/flu test rollout in U.S.

Executive Summary

• Microbix Biosystems Inc. has entered into a partnership with Sekisui Diagnostics LLC to support the U.S. commercialization of the Aptitude Medical Systems Metrix platform for COVID-19 and Influenza A/B testing.
• Microbix will provide its REDxFLOQ Quality Assessment Products (QAPs) to Sekisui, which will be included in kits to support operator training and ensure quality control for the new Metrix installations.
• The Metrix test is a 20-minute, three-plex molecular assay for SARS-CoV-2, Influenza A, and Influenza B, currently available in the U.S. under Emergency-Use Authorization (EUA).

Key Details

• Partnership Scope: Microbix is providing REDxFLOQ QAP kits to Sekisui Diagnostics to support the commercial rollout of the Aptitude Metrix platform in the United States.
• Product Function: The REDxFLOQ QAPs are designed to support the full patient-sample workflow, helping to avoid user errors and providing necessary controls for quality systems compliance.
• Kit Composition: The provided kits include a three-plex positive QAP and a negative QAP, compliant with full U.S. IVD regulations.
• Test Specifications: The Aptitude Metrix test is a single-use molecular assay using anterior nasal swab or saliva samples, delivering results in 20 minutes.
• Performance Metrics: The test has demonstrated 95% to 99% positive and negative concurrence with lab-based molecular assays.
• Regulatory Status: The test is authorized for use in the U.S. under an Emergency-Use Authorization (EUA) from the FDA.
• Distribution Agreement: This support follows an exclusive distribution agreement announced in January 2024 between Sekisui and Aptitude Medical Systems for the sale of the test in the U.S. market.
• Target Market: The test is designed for use by healthcare professionals and for at-home consumer use.

Notable Quotes

• David Morris, Associate Director, Product Management, Sekisui Diagnostics: "We're very excited to be commercializing Metrix and its tests into the U.S. market. We're also pleased to have Microbix and its REDxFLOQ QAPs to help users of this test, as we believe user training and providing these materials to those that need controls to comply with their quality systems is critical to our customer support."
• Phil Casselli, Senior Vice-President of Sales and Business Development, Microbix: "Microbix has enjoyed supporting Sekisui and Aptitude teams for the Metrix Covid/flu test. 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."