The collaboration will provide quality assessment products to support the commercialization of a molecular point-of-care assay for COVID-19 and influenza detection.
Microbix Biosystems Inc has partnered with Sekisui Diagnostics to provide quality assessment products supporting the US commercialization of a molecular point-of-care assay for COVID-19 and influenza diagnosis.
The collaboration involves Microbix’s REDx FLOQ Quality Assessment Products (QAPs) being used to support Sekisui’s commercialization of the Metrix COVID/Flu Test from Aptitude Medical Systems, Inc. The test is a 20-minute three-plex molecular assay for the detection of SARS-CoV-2, influenza A, or influenza B using anterior nasal swab or saliva samples.
The Metrix platform provides single-use molecular assays with a palm-sized instrument designed to enable molecular testing in various settings. The test has demonstrated 95-99% positive and negative concurrence with lab-based molecular assays and is available in the US under Emergency Use Authorization from the Food and Drug Administration.
Sekisui and Aptitude established an exclusive distribution agreement in January 2024 to sell the test in the US for use by healthcare professionals or at-home by consumers. Microbix is now supporting this commercialization with kits containing three-plex positive QAPs and negative QAPs designed to provide operator-training materials for new Metrix installations.
“We’re very excited to be commercializing Metrix and its tests into the US 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,” says David Morris, associate director of product management at Sekisui, in a release.
The REDxFLOQ QAPs are designed to support the full patient-sample workflow of the test and help avoid user errors. Microbix is providing the kits under full US in vitro diagnostic compliance.
“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,” says Phil Casselli, senior vice president of sales and business development at Microbix, in a release.
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