Genetic Testing Using Sysmex’s Assay Kit Receives Insurance Coverage as the First of Its Kind in Japan for Assessing the Risk of Adverse Reactions to Anti-Amyloid β Antibody Drugs
Sysmex Corporation (HQ: Kobe, Japan; President: Iwane Matsui) announces that PrismGuide™ APOE Genotyping Kit (“the assay kit”) has received the first insurance coverage in Japan, effective on July 1, 2026, for assessing the risk of adverse reactions to anti-amyloid β antibody drugs used to treat Alzheimer's disease.
Genetic testing using the assay kit makes it possible to assess the risk of adverse reactions before administering Alzheimer's disease medication to patients considering treatment. This is expected to contribute to shared decision-making (SDM),1 where the attending physician, patients, and their families consider treatment plans together based on the results.
While anti-amyloid β antibody drugs that act on the pathology of Alzheimer's disease are expected to slow the progression of dementia, some patients may experience an adverse reaction in the brain called amyloid-related imaging abnormalities (ARIA).2 Clinical evidence indicates that the incidence of ARIA varies depending on APOE genotype.3
The Guidelines for the Proper Use of APOE Genetic Testing for Dementia, Second Edition, which will be revised in July 2026,4 emphasizes the importance of considering treatment plans after fully understanding not only the effectiveness of treatment but also the risks of adverse reactions.
The assay kit is used to determine the APOE genotype from genomic DNA in the blood of patients considering administration of anti-amyloid β antibody drugs, and to assess the risk of adverse reactions. With the recent insurance coverage, it will become possible to utilize information on the risk of adverse reactions based on APOE genotypes in clinical settings as part of insured medical treatment for the first time in Japan. Going forward, its widespread use in clinical settings is expected to contribute to more appropriate drug administration decisions and the determination of treatment plans that respect patients' values.
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.
Product Overview
| Generic name (JMDN) | APOE Genotyping Kit |
|---|---|
| Product name | PrismGuide™ APOE Genotyping Kit |
In vitro diagnostics | 30700EZX00022000 |
| Intended use | APOE genotyping in genomic DNA extracted from whole blood |
| Manufacturer and seller | Sysmex Corporation |
| Target market | Japan |
Overview of National Health Insurance (NHI) Coverage in Japan
| NHI category | E3 (new item) |
|---|---|
| Item of measurement | APOE genotype |
| Measurement method | Real-time PCR method |
| NHI points | 2,274 |
| Points to consider | The following note is added to the points-to-consider section of "D006-17 Nudix hydrolase 15 (NUDT15) gene polymorphism." (1) omitted (2) For the APOE genotype, NHI points shall be calculated by applying the prescribed points for this category only once per patient, when the measurement is performed by the real-time PCR method for the purpose of determining whether or not to administer the drug, the treatment plan, etc., in patients and facilities that are eligible for administration of medication for suppressing the progression of mild neurocognitive disorder and/or mild dementia due to Alzheimer's disease as an indication or effect, as defined in the Guidelines for Promoting Optimal Use of Pharmaceuticals issued by the Ministry of Health, Labour and Welfare. |
Reference
Terminology
- 1Shared 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.
Source: Nakayama T., “Evidence-based Risk and Benefit Communication for Shared Decision Making,” YAKUGAKU ZASSHI 138, 331-334 (2018)
https://www.jstage.jst.go.jp/article/yakushi/138/3/138_17-00185-5/_pdf/-char/ja - *Japanese only
- 2Amyloid-Related Imaging Abnormalities
(ARIA):
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 - 3APOE 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. - 4Guidelines for the Proper Use of APOE Genetic Testing for Dementia:
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
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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- *The purpose of this news release is to communicate our business activities to our stakeholders. It may or may not include information about Sysmex's products or their research and development, but this is not intended for promotion, advertising, or medical advice. The information contained in this press release is current as of the date of the announcement but may be subject to change without prior notice.
