Research Support Through Measurement of Novel Coronavirus Antibodies and Cytokines
First written in FY2021-Q1. 4 of 7 entries say "Advanced", first in FY2021-Q2. Latest entry: FY2022-Q3.
1 other company's latest entry also says "Restated".
- FY2022-Q3RestatedAnnual report
「June 2021: Shionogi & Co., Ltd. obtained additional approval for the HISCL™ TARC Reagent, a Th2 chemokine TARC kit jointly developed with the company, for the intended use of supporting assessment of the risk of severe disease in patients who test positive for COVID-19. This product is used with the company's HISCL-5000/HISCL-800 fully automated immunoassay analyzers.」
The company has reiterated the additional approval of the HISCL™ TARC Reagent for use in supporting assessment of the risk of severe disease in patients who test positive for COVID-19. - FY2022-Q2RestatedAnnual report
「June 2021: Shionogi & Co., Ltd. obtained additional approval for the HISCL™ TARC Reagent, a Th2 chemokine TARC kit jointly developed with the company, for the intended use of supporting assessment of the risk of severe disease in patients who test positive for COVID-19. This product is used with the company's HISCL-5000/HISCL-800 fully automated immunoassay analyzers.」
The company has reiterated the additional approval of the HISCL™ TARC Reagent for use in supporting assessment of the risk of severe disease in COVID-19-positive patients. - FY2022-Q1AdvancedAnnual report
「June 2021: Shionogi & Co., Ltd. obtained additional approval for the HISCL™ TARC Reagent, a Th2 chemokine TARC kit jointly developed with the company, for the intended use of supporting assessment of the risk of severe disease in patients who test positive for COVID-19. This product is used with the company's HISCL-5000/HISCL-800 fully automated immunoassay analyzers.」
For COVID-19-related cytokine measurement, the HISCL™ TARC Reagent obtained additional approval for use in supporting assessment of the risk of severe disease in positive patients. The product has progressed from research-use measurement to clinical use. - FY2021AdvancedAnnual report
「February 2021: The HISCL™ IFN-λ3 Reagent interferon-λ3 kit manufactured and marketed by the company became eligible for health insurance coverage as a test kit to support assessment of the risk of severe disease in SARS-CoV-2-positive patients.」
Building on research-use antibody and cytokine measurement, the IFN-λ3 kit obtained health insurance coverage as a test kit to support assessment of the risk of severe disease. - FY2021-Q3AdvancedAnnual report
「December 2020: The company obtained marketing approval for the interferon-λ3 kit HISCL™ IFN-λ3 Reagent. By measuring interferon-λ3 in serum using this product and the fully automated immunoassay analyzers HISCL™-5000/HISCL™-800, the product provides information to support assessment of the risk of severe disease in SARS-CoV-2-positive patients.」
Building on its COVID-19-related research involving antibody and cytokine measurement, the company obtained marketing approval for the IFN-λ3 kit and established its use to support assessment of the risk of severe disease in SARS-CoV-2-positive patients. - FY2021-Q2AdvancedAnnual report
「June 2020: The company, Kobe City, the Kobe Biomedical Innovation Cluster Promotion Organization and the Kobe City Medical Center General Hospital of the Kobe City Hospital Organization began efforts toward the clinical implementation of a new testing workflow using SARS-CoV-2 antigen and antibody testing and immunological pathophysiological testing methods developed by the company. July 2020: The company began offering contract cytokine measurement services for research use, with cytokines indicated to be useful markers for assessing the risk of severe COVID-19 and monitoring treatment efficacy.」
In addition to contract research involving antibody detection reagents, the company began work toward the clinical implementation of a new antigen and antibody testing and immunological pathophysiological testing workflow in cooperation with Kobe City and others, and began offering contract cytokine measurement services for research use. - FY2021-Q1First statedAnnual report
「June 2020: The company developed four research-use antibody detection reagents capable of detecting IgG and IgM antibodies in blood that specifically react with the nucleocapsid protein (the "N antigen") and spike protein (the "S antigen") of the virus that causes COVID-19 (SARS-CoV-2). It began offering contract research services. The company, the National Cancer Center and the National Center for Global Health and Medicine conducted joint research on SARS-CoV-2 antigen and antibody testing methods. In a comparison of blood concentrations of IgG antibodies against the N and S antigens between a SARS-CoV-2-negative group and a SARS-CoV-2 patient group at discharge, using the aforementioned reagents developed by the company, the results showed clear discriminatory performance.」
The company developed 4 research-use reagents to detect IgG and IgM antibodies reacting to the N and S antigens and began offering contract research services. A joint study with the National Cancer Center and the National Center for Global Health and Medicine confirmed their discriminatory performance, and the company also began offering contract cytokine measurement services for research use.