High-Sensitivity Immunoassays for Liquid Biopsies and the Practical Application of Biomarkers
First written in FY2018. 12 of 13 entries say "Advanced", first in FY2020-Q2. Latest entry: FY2025-H1.
3 other companies' latest entry also says "Advanced".
- FY2025-H1AdvancedAnnual report
「September 2024: The company filed an application in Japan for marketing approval of a test reagent that determines APOE genotype from genomic DNA in blood to predict the risk of adverse reactions to anti-amyloid beta antibody drugs.」
In its high-sensitivity immunoassay and biomarker business, the company filed a domestic approval application for an APOE genotype test reagent that predicts the risk of adverse reactions to anti-amyloid beta antibody drugs, expanding its Alzheimer’s disease-related applications. - FY2024AdvancedAnnual report
「January 2024: Following Japan and the United States, the company expanded sales of an Aβ assay reagent in Europe that examines the accumulation of Aβ in the brain, considered a cause of Alzheimer’s disease, using a small blood sample.」
Expanded the sales region for the blood amyloid beta assay reagent from Japan and the United States to Europe. - FY2024-Q2AdvancedAnnual report
「August 2023: We began supplying a major testing laboratory in the United States with a reagent for measuring amyloid beta in blood as a reagent for laboratory-developed tests (LDTs). This LDT assists in assessing the accumulation of Aβ in the brain, which is considered a cause of Alzheimer's disease.」
In its high-sensitivity immunoassay and biomarker business, the company began supplying a blood amyloid beta assay reagent for LDTs in the United States, advancing its practical application overseas. - FY2024-Q1AdvancedAnnual report
「③ June 2023: We launched in Japan the HISCL™ β-Amyloid 1-42 Reagent and HISCL™ β-Amyloid 1-40 Reagent, which examine the accumulation of amyloid beta (Aβ) in the brain, a cause of Alzheimer’s disease, using a blood sample.」
As an application of liquid biopsy and high-sensitivity immunoassay technologies, the company launched a blood Aβ assay reagent in Japan, advancing it from the research and approval stages to market introduction. - FY2023-Q3AdvancedAnnual report
「⑩ December 2022: We obtained domestic marketing approval for the HISCL β-Amyloid 1-42 Reagent and HISCL β-Amyloid 1-40 Reagent, which measure amyloid beta (Aβ) in blood, as in vitro diagnostic products.」
The blood amyloid beta measurement reagents progressed from European IVD Directive self-declaration to obtaining domestic marketing approval as in vitro diagnostic products. - FY2023-Q1AdvancedAnnual report
「May 2022: We completed the European IVD Directive self-declaration for reagents that measure amyloid beta in blood using the fully automated HISCL™-5000/HISCL-800 immunoassay analyzers and assist in assessing the accumulation of amyloid beta in the brain.」
The European IVD Directive self-declaration was completed for the HISCL blood amyloid beta measurement reagents, advancing regulatory preparations for the European rollout of dementia-related biomarker testing. - FY2022-Q3AdvancedAnnual report
「December 2021: We submitted an application for marketing approval of reagents that measure amyloid beta in blood using the fully automated HISCL-5000/HISCL-800 immunoassay analyzers and assist in assessing the accumulation of amyloid beta in the brain.」
An application for marketing approval was submitted for a reagent measuring amyloid beta in blood using HISCL, advancing the commercialization of a test to support the early initiation of treatment for Alzheimer’s disease dementia. - FY2021AdvancedAnnual report
「We presented the latest data at the 15th International Conference on Alzheimer’s and Parkinson’s Diseases on a blood-based diagnostic method for Alzheimer’s disease being jointly developed with Eisai Co.,Ltd.」
We have continued presenting research findings on biomarker-based diagnosis using blood and plasma, expanding the application of liquid biopsy. - FY2021-Q3AdvancedAnnual report
「November 2020: We presented the latest data at the 13th Clinical Trials on Alzheimer’s Disease conference on a plasma-based diagnostic method for Alzheimer’s disease being jointly developed by our Company and Eisai Co.,Ltd.」
We presented the latest data at the 13th Clinical Trials on Alzheimer’s Disease conference on the plasma-based diagnostic method for Alzheimer’s disease being developed jointly with Eisai Co.,Ltd. - FY2020AdvancedAnnual report
「We presented academic findings at the 12th Clinical Trials on Alzheimer’s Disease conference (CTAD) concerning the development, jointly with Eisai Co.,Ltd., of a blood-based diagnostic method for Alzheimer’s disease. At CTAD, we announced findings suggesting that plasma amyloid beta (Aβ) measured using our protein measurement platform, the fully automated HISCL™ immunoassay analyzer series, may enable assessment of amyloid pathology in the brain.」
Academic findings suggested that brain amyloid pathology may be assessed through plasma Aβ measurement using the HISCL™ series, expanding the application of liquid biopsy and high-sensitivity testing. - FY2020-Q3AdvancedAnnual report
「At CTAD, we announced findings suggesting that plasma amyloid beta (Aβ) measured using our protein measurement platform, the fully automated HISCL™ immunoassay analyzer series, may enable assessment of amyloid pathology in the brain.」
The Company published academic findings on the possibility of assessing brain amyloid pathology by measuring plasma Aβ using the HISCL™ series, expanding the application of biomarker testing. - FY2020-Q2AdvancedAnnual report
「Since 2013, our Company and Specially Appointed Professor Tasuku Honjo (本庶 佑) of the Institute for Advanced Study at Kyoto University, a national university corporation, have jointly conducted R&D aimed at creating new diagnostic technologies in oncology and immune diseases. We recently established a fully automated assay method for soluble immune checkpoint molecules (sPD-1, sPD-L1 and sCTLA-4) using the research-use fully automated high-sensitivity immunoassay analyzer HI-1000, and began offering contract research services using this method in September 2019. This assay method may become a new diagnostic method for cancer immunotherapy and various autoimmune diseases, contributing to the realization of personalized medicine.」
We established a fully automated assay method for soluble immune checkpoint molecules using HI-1000 and began offering contract research services in September 2019. - FY2018First statedAnnual report
「To achieve personalized medicine through liquid biopsy, we launched the research-use fully automated high-sensitivity immunoassay analyzer HI-1000. By achieving sensitivity from several dozen to several thousand times higher than conventional methods, the analyzer can detect proteins at concentrations below pg/mL and measure extremely low concentrations of blood biomarkers that were previously difficult to measure.」
We launched HI-1000 with the aim of achieving personalized medicine through liquid biopsy. In addition to high-sensitivity immunoassay testing, we plan to provide services including reagent development, measurement condition setting, raw material development and production, and contract testing.