Mr. Cameron Groome reports

MICROBIX PARTNERS WITH SEKISUI DIAGNOSTICS TO SUPPORT COVID/FLU TESTS

Microbix Biosystems Inc. external third party quality assessment products (REDxFLOQ QAPs) will be used to support Sekisui Diagnostics LLC's United States commercialization of the molecular point-of-care assay for diagnosis of Covid/Flu A/Flu B using the Metrix platform from Aptitude Medical Systems Inc.

Aptitude provides single-use molecular assays for qualitative detection of pathogens using anterior nasal swab or saliva samples, giving highly accurate results with a low-cost instrument fitting in the palm of the hand. Its objective is to enable molecular testing to be done anywhere and everywhere. The Metrix Covid/flu test is a 20-minute three-plex molecular (that is, nucleic acid amplification) assay for accurate detection and diagnosis of infection with SARS-COV-2, Influenza A or Influenza B. The Test has shown 95- to 99-per-cent positive and negative concurrence with lab-based molecular assays and is being made available in the U.S. under an Emergency-Use Authorization from the U.S. Food and Drug Administration.

Sekisui is a well-known provider of rapid diagnostics to both professional and home testing markets. As announced in January, 2024, Sekisui and Aptitude formalized an exclusive distribution agreement to sell the test in the U.S., where it can be performed by health care professionals or at home by consumers. Microbix is now supporting Sekisui's commercialization of the test with kits of its REDxFLOQ QAPs to provide new Metrix installations with operator-training materials. The REDxFLOQ QAPs are designed to support the full patient-sample workflow of the test and thereby help avoid any user errors. Microbix is providing kits comprised of a three-plex positive QAP and a negative QAP, under full U.S. IVD compliance.

David Morris, associate director, product management, at Sekisui, commented: "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, at Microbix, also commented: "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."

About Sekisui Diagnostics LLC

With over 40 years of experience, Sekisui Diagnostics' mission is to provide intelligent solutions to enhance life with science and improve the health of all people. Sekisui supplies innovative medical diagnostics globally to physicians, hospitals, laboratories and alternate testing locations. The company's product lines include clinical chemistry reagents, point-of-care tests, preanalytic systems, as well as enzymes and specialty biochemicals.

About Microbix Biosystems Inc.

Microbix creates proprietary biological products for human health, with over 120 skilled employees and revenues of $25.4-million in its latest fiscal year. It makes and exports a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs) and reference materials (QUANTDx) supporting POCT and clinical lab EQA, enabling assay development and validation, or helping ensure the quality of clinical diagnostic workflows. Its antigens drive the tests of approximately 100 diagnostics makers, while QAPs or QUANTDx are sold to clinical lab accreditation organizations, diagnostics companies and clinical labs. Microbix QAPs are now available in over 30 countries, supported by a network of international distributors. Microbix is ISO 9001 and 13485 accredited, United States Food and Drug Administration registered, Australian TGA registered, Health Canada establishment licensed and provides IVDR-compliant CE marked products.

We seek Safe Harbor.