Development of in vitro diagnostic products for Entamoeba histolytica infection
First written in FY2021. 3 of 8 entries say "Advanced", first in FY2023. Latest entry: FY2026.
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- FY2026AchievedAnnual report
「The Company has obtained marketing approval for the in vitro diagnostic product “Amoebic Dysentery Antibody ELISA-IBL,” which can be used to check for amoebic dysentery infection through a simple blood test. The product has been covered by insurance and sales have begun.」
The Entamoeba histolytica diagnostic reagent progressed from awaiting reimbursement coverage to being launched, following the acquisition of marketing authorisation and reimbursement coverage. - FY2025The expected timing of reimbursement coverage was specified.Annual report
「We have obtained marketing authorisation for the in vitro diagnostic reagent (product name: Entamoeba histolytica Antibody ELISA-IBL), plan to apply for reimbursement coverage in the first quarter, and expect coverage to be obtained by December 2025.」
Following approval of the Entamoeba histolytica diagnostic reagent, an application for reimbursement coverage was scheduled for the first quarter, with coverage expected by December 2025. - FY2024AdvancedAnnual report
「We have obtained marketing authorisation for the in vitro diagnostic reagent (product name: Entamoeba histolytica Antibody ELISA-IBL). We are currently preparing for reimbursement coverage and will begin sales once coverage is obtained.」
The in vitro diagnostic reagent for Entamoeba histolytica has received marketing authorisation and advanced to the stage of awaiting the start of sales following reimbursement coverage. - FY2024-Q1AdvancedAnnual report
「The application for marketing authorisation for the in vitro diagnostic reagent for Entamoeba histolytica, which had been scheduled for the first quarter of the fiscal year ending March 2024, was completed in June 2023. Sales will begin after the application is approved and reimbursement coverage is obtained.」
The application for regulatory approval of the in vitro diagnostic reagent for Entamoeba histolytica infection, which had been planned, was completed in June 2023, and the product advanced to the stage of awaiting approval, reimbursement coverage and the start of sales. - FY2023AdvancedAnnual report
「Preparations are currently under way for an application for marketing authorisation for the in vitro diagnostic reagent during the first quarter of the fiscal year ending March 2024.」
The in vitro diagnostic reagent for Entamoeba histolytica infection advanced to the preparation stage for an approval application during the first quarter of the fiscal year ending March 2024. - FY2021First statedAnnual report
「We are therefore developing an in vitro diagnostic reagent that can check for Entamoeba histolytica infection through a simple blood test. We had planned to apply for marketing authorisation for the in vitro diagnostic reagent in the fourth quarter of the fiscal year ending March 2022.」
The development of an in vitro diagnostic reagent to confirm Entamoeba histolytica infection through a blood test, and the planned application for approval in the fourth quarter of the fiscal year ending March 2022, were described for the first time.