Press Release
Sysmex Corporation (HQ: Kobe, Japan; President: Kaoru Asano) 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 (“the 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.
February 15, 2016 news release: “Sysmex and Eisai Enter Comprehensive Agreement to Create Next-generation Diagnostic Reagents in the Field of Dementia”
https://www.sysmex.co.jp/en/news/2016/160215.html |
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June 27, 2022 news release: “Completion of Declaration of Conformity to the European IVD Directive for an Assay Kit that Measures Plasma Amyloid Beta (Aβ) Using the Automated Immunoassay System HISCL™-5000/HISCL™-800”
https://www.sysmex.co.jp/en/news/2022/pdf/220627.pdf |
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June 22, 2023 news release: “Sysmex Launches an Assay Kit to Identify Amyloid Beta (Aβ) Accumulation in the Brain, a Cause of Alzheimer’s Disease, Using a Small Amount of Blood” https://www.sysmex.co.jp/en/news/2023/230622.html |
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August 29, 2023 news release: “Sysmex Begins Supplying Reagents for U.S. Based Laboratory Developed Test (LDT) Measuring Amyloid Beta (Aβ) in Blood”
https://www.sysmex.co.jp/en/news/2023/230829.html |
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Laboratory Developed Test: LDT
A laboratory developed test (LDT) is a type of in vitro diagnostic test that is designed, manufactured, and used within a single laboratory. |
2. | Sysmex promotes the concept of a “healthcare journey.” We view the various healthcare-related events a person experiences throughout their lives (life stages), along with the corresponding processes these involve (such as treatment at healthcare institutions), as a “journey”. Through various collaborations, we aim to offer new value, to make each individual’s healthcare journey better, and to grow as an essential presence in society. |
Sysmex Corporation, headquartered in Kobe, Japan, is a global leader in in vitro diagnostics. Since its foundation in 1968, Sysmex has focused on diagnostics as the core of its business, and today, it supports the health of people in over 190 countries and regions worldwide. Sysmex continues to innovate in diagnostics, and to collaboratively create unique values in the areas of personalized medicine and novel treatments, under its long-term vision of "Together for a better healthcare journey." Through its unique technology, solutions, and co-creation with various partners, Sysmex delivers new value and addresses the universal desire of people to live longer and healthier lives.
For more information about Sysmex, please visit www.sysmex.co.jp/en/.
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