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Sysmex Obtains Manufacturing and Marketing Approval for Japan's First Assay Kit Assessing the Risk of Adverse Reactions to Anti-Amyloid β Antibody Drugs for Alzheimer’s Disease
Sysmex Corporation (HQ: Kobe, Japan; President: Kaoru Asano) announces that it has received the first manufacturing and marketing approval in Japan for PrismGuide™ APOE Genotyping Kit, an assay kit that determines the APOE genotype1 in blood genomic DNA ("the assay kit"), on June D, 2025, following the company's application in September 2024.
It is expected that the assay kit, which has obtained the first manufacturing and marketing approval in Japan, will predict the risk in patients with Alzheimer's disease of side effects from anti-amyloid β antibody drugs, a treatment for Alzheimer's disease, thereby contributing to shared decision-making (SDM) between attending physicians and patients and their families.2 To implement the assay kit in society in accordance with the Proper Use Guidelines3 formulated in March 2025, we will continue collaborating with dementia-related academic societies to obtain insurance coverage for the assay kit.
Sysmex has obtained manufacturing and marketing approval for Japan’s first assay kit that identifies six APOE genotypes.6 The assay kit is intended to assist in determining the risk of developing ARIA during anti-amyloid β antibody drug administration. If the assay kit becomes available in clinical settings in the future, it is expected to assist in shared decision-making (SDM), in which attending physicians, patients, and their families discuss the risk of ARIA and decide together on treatment methods before using anti-amyloid β antibody drugs. Going forward, we will continue to work towards the social implementation and insurance coverage of the assay kit, in collaboration with dementia-related academic societies.
At Sysmex, we will continue to support each individual’s healthcare journey, contributing to the selection of the appropriate treatment method and the creation of new value for a healthy society.
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| September 17, 2024 news release: "Sysmex Applies for Manufacturing and Marketing Approval of an Assay Kit to Predict the Risk of Adverse Reactions from Anti-amyloid β Antibody Drugs for Alzheimer’s Disease" |
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| https://www.sysmex.co.jp/en/news/2024/240917.html |
| 1 | APOE genotype: A gene encoding apolipoprotein E (ApoE), which is involved in lipid metabolism. Three genotypes (ε2, ε3, and ε4) are defined by the combination of two single-nucleotide substitutions (rs429358 and rs7412) encoding amino acids at positions 112 and 158. The incidence of ARIA is highest in APOE ε4 homozygotes (ε4*4) , followed by ε4 heterozygotes (ε2*4, ε3*4), and non-ε4 carriers (ε2*2, ε2*3, ε3*3). In particular, APOE ε4 homozygotes are more likely to manifest symptomatic ARIA than other genotypes. APOE genotype determined by this assay and risk of ARIA development after administration of anti-amyloid β antibody drugs
performed prior to the initiation of treatment to determine the risk of developing ARIA. Prior to testing, prescribers should discuss with patients the risk of ARIA across genotypes and the implications of genetic testing results. It is also stated that prescribers should inform patients that if APOE genotype testing is not performed they can still be treated with these therapeutics, although they cannot be judged to be at higher risks of developing ARIA due to APOE ε4 homozygosity. In addition, the product information for anti-amyloid β antibody drugs approved in Europe states that their use is limited to ε4 heterozygotes and non-ε4 carriers. *US: US Food and Drug Administration (FDA) Approved Drug Database, Europe: EUROPEAN MEDICINES AGENCY Database) [accessed on June 13, 2025 ] LEQEMBI（nonproprietary name：lecanemab-irmb） United States: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761269s005lbl.pdf Europe: https://www.ema.europa.eu/en/documents/product-information/leqembi-epar-product-information_en.pdf Kisunla（nonproprietary name：donanemab-azbt） United States: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761248s000lbl.pdf |
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| 2 | Shared decision making (SDM): | |||||||||||||||||
| To promote patient participation in the treatment decision-making process and to have attending physicians work together with patients to make better choices for them. Report on the research project "Examining the Significance and Potential of Shared Decision Making (SDM)" funded by the Ministry of Health, Labour and Welfare's Science Research Grant (Comprehensive Research Project for Promoting Cancer Control) https://mhlw-grants.niph.go.jp/system/files/report_pdf/202008039A-buntan10.pdf *Japanese only |
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| 3 | Proper Use Guidelines: | |||||||||||||||||
| Guidelines for the Proper Use of APOE Genetic Testing for Dementia, First Edition, March 31, 2025 ("Guidelines for the Proper Use of APOE Genetic Testing for Dementia" Drafting Committee) https://dementia-japan.org/wp-content/uploads/2025/04/apoeguideline2025.pdf *Japanese only |
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| 4 | Amyloid-Related Imaging Abnormalities： | |||||||||||||||||
| Amyloid-Related Imaging Abnormalities (ARIA) are divided into two types: ARIA-E and ARIA-H. The former is characterized by edema with liquid material accumulated around the brain blood vessels. The latter is manifested with microhemorrhages and iron (hemosiderin) deposits in the brain. Although ARIA is usually asymptomatic, serious events have been reported in rare cases. Source：Hampel H.et al. Amyloid-related imaging abnormalities (ARIA): radiological, biological and clinical characteristics, Brain. 146, 4414-4424 (2023) https://doi.org/10.1093/brain/awad188 |
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| 5 | Sources： | |||||||||||||||||
| van Dyck CH., et al. Lecanemab in early Alzheimer's disease. New Engl J Med. 388, 9-21 (2023) https://www.nejm.org/doi/full/10.1056/NEJMoa2212948 Sims JR. et al. Donanemab in early symptomatic Alzheimer disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial. JAMA 330 512-527 (2023) https://jamanetwork.com/journals/jama/fullarticle/2807533 |
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| 6 | The performance evaluation related to the development of this product was conducted in collaboration with Niigata University, and the clinical performance tests required for this approval were conducted in collaboration with Eisai Co., Ltd. |
About Sysmex Corporation
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/.
* "Healthcare journey" is a trademark of Sysmex Corporation, registered in Japan.
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