Development of the CTP Measurement System as an In Vitro Diagnostic Product
First written in FY2016. 4 of 9 entries say "Advanced", first in FY2020. Latest entry: FY2026.
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- FY2026AdvancedAnnual report
「The Company is jointly developing CTP measurement reagents based on the simple and rapid immunochromatographic method with Saitama Medical University, a school corporation.」
For the CTP measurement system, the Company is jointly developing simple, rapid immunochromatographic measurement reagents with Saitama Medical University, in addition to the existing ELISA product Cosmic. - 2026-05-28ReframedEarnings presentation
「CTP (Cochlin-Tomo-Protein) immunochromatographic method」
CTP was included in the business plan as a development project using an immunochromatographic method, with the status of insurance coverage continuing to be presented. The materials do not expressly state its relationship with the existing CTP assay system. - FY2023AdvancedAnnual report
「The in vitro diagnostic received approval in June 2020 and was subsequently covered by national health insurance, effective 1 July 2022, for use as an aid in diagnosing patients suspected of having a perilymphatic fistula (reimbursement: 460 points).」
Following approval as an in vitro diagnostic, the CTP measurement system was covered by national health insurance in July 2022, with a reimbursement of 460 points. The Company is responsible for manufacturing. - FY2021AdvancedAnnual report
「株式会社コスミックコーポレーション has obtained marketing approval for an in vitro diagnostic and is currently applying for insurance coverage.」
The CTP measurement system has progressed from the approval application and regulatory consultation stage to the stage of obtaining marketing approval for an in vitro diagnostic and applying for insurance coverage. - FY2020AdvancedAnnual report
「Regarding CTP (cochlintomo-protein), a biomarker for hearing loss and vertigo owned by Saitama Medical University, an application for approval to manufacture and market an in vitro diagnostic product was submitted on 26 June 2019, and discussions are being held with the FDA.」
The CTP measurement kit was submitted for approval and has progressed to the consultation stage with the regulatory authorities. - FY2019RestatedAnnual report
「Currently, コスミックコーポレーション is leading the collection of data and preparation of materials for the application for approval of the in vitro diagnostic product. Once approval is obtained, we will receive royalties based on sales. In addition, we aim to expand sales in the future by manufacturing the product ourselves.」
For the CTP measurement kit, the company continues to prepare the application for approval under the leadership of コスミックコーポレーション, with plans for the company to manufacture the product and receive royalty income. - FY2018-Q1RestatedAnnual report
「Currently, the company is leading the collection of data and preparation of materials for the application for approval of the in vitro diagnostic product. If the application is approved, we will receive royalties based on sales. In addition, we will manufacture the product ourselves, and expect sales to increase in the future.」
For the CTP assay system, the company continues to prepare the application for approval under the leadership of コスミックコーポレーション, with plans for the company to manufacture the product and receive royalty income. - FY2017RestatedAnnual report
「Currently, コスミックコーポレーション is leading the collection of data and preparation of materials for the application for approval of the in vitro diagnostic product. Once approval is obtained, we will receive royalties based on sales. In addition, we expect future sales growth from manufacturing the product ourselves.」
For the CTP in vitro diagnostic product, the company continues to collect data and prepare materials under the leadership of コスミックコーポレーション. - FY2016First statedAnnual report
「As a result, we will achieve the early submission of an application for approval and commercialization of the in vitro diagnostic product, while receiving an upfront payment and royalties based on sales under the sublicense agreement. We also aim to expand sales by manufacturing the product ourselves.」
The company transferred the domestic regulatory filing and sales rights to コスミックコーポレーション and aims to secure approval, commercialize the product and manufacture it in-house.