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Sysmex (6869) · InitiativeAchieved

Accelerating COVID-19 antigen testing using the HISCL automated immunoassay system

First written in FY2021-Q2. 1 of 2 entries say "Achieved", first in FY2021-Q3. Latest entry: FY2021-Q3.

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2years
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ProgressHeldSoftenedWorseFirst statedFY2021-Q22020: 120202021: 12021
Same theme, other companies
Approval and Reimbursement Coverage for COVID-19 Antigen Testing Reagents for HISCLA theme 1 companies write about · 0 as a headwind · 1 as a tailwind

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  1. FY2021-Q3AchievedAnnual report

    「November 2020: The company obtained marketing approval as an in vitro diagnostic for the HISCL™ SARS-CoV-2 Ag Reagent, a SARS coronavirus antigen kit capable of detecting SARS-CoV-2 antigen using its HISCL™-5000/HISCL™-800 fully automated immunoassay analyzers, and the product became eligible for health insurance coverage.」

    For the SARS-CoV-2 antigen testing reagent used with the HISCL™-5000/HISCL™-800, the company obtained marketing approval and health insurance coverage, advancing from the approval application stage reported in the previous quarter.
  2. FY2021-Q2First statedAnnual report

    「Against this backdrop, the company submitted an application for marketing approval of a testing reagent for detecting the antigen of SARS-CoV-2, the coronavirus that causes COVID-19, using the HISCL™-5000/HISCL™-800 fully automated immunoassay analyzers. The reagent detects SARS-CoV-2 antigen in nasopharyngeal swab specimens. Used with the HISCL™-5000/HISCL™-800, it provides highly sensitive test results and enables rapid testing with a reaction time of 17 minutes, as well as processing capacity of 200 tests per hour on the HISCL™-5000, thereby improving testing efficiency.」

    The company submitted an application for marketing approval of a SARS-CoV-2 antigen testing reagent used with the HISCL™-5000/HISCL™-800, targeting rapid, highly efficient testing with a 17-minute reaction time and processing capacity of 200 tests per hour on the HISCL™-5000.
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Accelerating COVID-19 antigen testing using the HISCL automated immunoassay system | SYSMEX CORPORATION (6869) | Komori