Sales and Expanded Applications of the Muscular Dystrophy Titin Measurement Kit
First written in FY2017. 4 of 8 entries say "Softened", first in FY2025. Latest entry: FY2026.
No other company in this theme has enough history to compare yet.
- FY2026SoftenedAnnual report
「To concentrate development resources on other development themes, sales of this kit were changed from an accredited test reagent to a research reagent.」
Although the tyrosine measurement system stated a target of filing for approval in the fiscal year ending March 2026, the sales format was changed from certified testing reagents to research-use reagents due to a concentration of resources on other projects, weakening efforts to develop an approved drug. - FY2025SoftenedAnnual report
「The company is developing an ELISA kit to measure titin, a protein found in the urine of patients with neuromuscular diseases, as a marker for diagnosing neuromuscular diseases and monitoring disease status, with the aim of applying for marketing approval in the fiscal year ending March 2026.」
The target timing for the titin assay approval application was pushed back from the fiscal year ending March 2025 to the fiscal year ending March 2026. Sales as an accredited test reagent are continuing. - FY2023ReframedAnnual report
「The target disease was changed from muscular dystrophy to neuromuscular diseases, and research and development will continue with the aim of applying for approval as an in-vitro diagnostic in the fiscal year ending March 2025. Until approval is obtained as an in-vitro diagnostic, the product was approved following an application for confirmation as an accredited reagent so that it could be sold as a research reagent, and sales have begun as an accredited reagent.」
The titin assay expanded its target diseases from muscular dystrophy to neuromuscular diseases, and the target timing for the approval application was set as the fiscal year ending March 2025. Sales as an accredited reagent before approval also began. - FY2021AdvancedAnnual report
「The company has developed an assay for titin, a protein found in the urine of patients with muscular dystrophy, as a marker for diagnosing muscular dystrophy and monitoring disease status, and has begun selling it as a research reagent. It plans to submit an application for marketing approval as an in-vitro diagnostic during the fiscal year ending March 2022 and is currently preparing the application.」
The titin assay progressed from sales as a research reagent to the preparation stage for an application for approval as an in-vitro diagnostic during the fiscal year ending March 2022. - FY2020AdvancedAnnual report
「The company plans to submit an application for marketing approval as an in-vitro diagnostic in October 2020 and is preparing the application.」
For the titin assay kit, the company disclosed plans to apply for approval in October 2020 and the preparation stage for converting it from a research reagent into an in-vitro diagnostic. - FY2017First statedAnnual report
「The company had been developing an assay for the protein titin found in the urine of patients with muscular dystrophy as a biomarker for diagnosing muscular dystrophy, and began selling it as a research reagent in November 2016.」
Sales of the titin assay began as a research reagent, and expansion into muscular dystrophy diagnosis, disease-state monitoring and exercise monitoring is under way.