指定 against Sisumetukusu K.K.
Action summary
- Company
- Sisumetukusu K.K.RomanizedOriginal: シスメックス株式会社Corporate Number: 9140001009530
- Governing law
- 薬事法薬事法
- Action type
- 指定指定
- Action date
- February 28, 2017
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
A DNA sequencer diagnostic system that comprehensively tests for mutations, amplifications, and fusions of cancer-related genes, used for genetic abnormality profiling of cancer patients and assisting in clinical decision-making. There are no domestically approved products, and future plans include conducting necessary tests to substantiate the usefulness of cancer-related gene abnormality profiling and submitting an approval application in Japan ahead of the world.
Show original Japanese text
がん関連遺伝子の変異・増幅・融合を網羅的に検査するDNAシークエンサー診断システムであり、がん患者の遺伝子異常プロファイリングを行い、診療方針決定の補助に用いる。国内で承認されたものがなく、今後、がん関連遺伝子異常プロファイリングの有用性を裏付けるために必要な試験を行い、世界に先駆けて日本で承認申請予定。
Source
Original Ministry of Health, Labour and Welfare announcement (in Japanese)The original Japanese disclosure is the authoritative record.
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Language
日本語版を見る (Japanese)Company info
- English name
- Sisumetukusu K.K. Romanized
- Japanese name
- シスメックス 株式会社
- Corporate Number
- 9140001009530
- Registered address
- 兵庫県神戸市中央区脇浜海岸通１丁目５番１号
About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.