Sysmex Corp. announces that, following their introduction in Japan and the United States, its reagents used for blood testing to identify Amyloid Beta (Aβ) accumulation in the brain—thought to be a leading cause of Alzheimer’s disease, will be expanded to Europe starting January 2024.
These reagents, the HISCL β-Amyloid 1-42 and 1-40 assay kits, have attained CE-IVD marking as of May 17, 2022. Going forward, Sysmex will continue to promote activities towards expanding our testing parameters, including the assay kits, accelerating the deployment of our immunochemistry testing business in Europe.
With dementia becoming a global social problem, Sysmex has been focusing its efforts on commercialization and market expansion for blood biomarkers that enable minimally invasive, simple, and rapid testing for the disease. As one such biomarker, the company has developed reagents for use with its HISCL-5000/HISCL-800 Automated Immunoassay System (HISCL-Series) in identifying the Aβ accumulation in the brain from a small amount of blood. In addition to launching the assay kits as in vitro diagnostic products in Japan in June 2023, Sysmex has started supplying them for the U.S. laboratory developed test market in August 2023.
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In Europe, since completing the declaration of conformity to the European IVD Directive (IVDD) for the assay kits in May 2022, Sysmex has been accumulating evidence through collaborative research with Key Opinion Leaders (KOLs). In order to expand its clinical application, the company has been working on regulatory compliance for the analyzers and common reagents that are used alongside the assay kits. The company has now completed the declaration of conformity to the European IVD regulation (IVDR) for these analyzers and common reagents. With these regulatory milestones achieved, Sysmex is set to expand the market for the assay kits in medical institutions across Europe from January 2024 onwards.
The assay kits, diagnostic reagents that measure Alzheimer’s disease-related blood biomarkers, meet the requirements for CE-IVD marking in Europe for use on a fully automated immunoassay platform. They allow for minimally invasive, affordable testing with just a small amount of blood for patients suspected of having Aβ accumulation in the brain. In addition, the testing process can be done easily and rapidly (in just 17 minutes for measurement) using Sysmex’s HISCL-Series analyzers. There is expected to be a growing demand for the assay kits because they can help ensure the proper use and clinical implementation of Alzheimer’s disease-modifying drugs, which have been actively developed in recent years.
Going forward, Sysmex will work on expanding testing parameters including the assay kits in order to accelerate the development of its immunochemistry testing business in Europe, the company says.
