内容紹介
Current Situation and Challenges in Companion Diagnostics Development
Summary
The personalized health care, it is defined as a medical care which provide the optimal therapy for each individual in consideration of a patient's individual difference, such as a genetic background and a physiological state. A companion diagnosis to stratify a patient appropriately is essential for the spread of personalized health care, and it is important that a companion diagnostic reagent used for the companion diagnosis is properly developed and clinically applied. However, as for the development of companion diagnostics and pharmaceuticals that require it, there are still many challenges such as its business model of cooperation of diagnostics companies and pharmaceutical companies, also, the regulations related to companion diagnostics. Furthermore, even in clinical practice, there are many issues such as the way of reimbursement for companion diagnostics and also the handling of laboratory developed test(LDT)as companion diagnostics. These are issues that should continue to discuss with industry, government and academia. In this report, from the point of view of a diagnostics company, we discuss the various challenges in clinical applications from the development of companion diagnostics.
要旨
個別化医療とは,遺伝的背景や生理的状態など患者の個人差に考慮して各個人に最適な治療法を提供する医療と定義される。個別化医療の普及には,患者を適切に層別化するためのコンパニオン診断が不可欠であり,そのコンパニオン診断に用いられるコンパニオン診断薬が適切に開発,臨床応用されていくことが重要である。しかしながら,コンパニオン診断薬とそれを必要とする医薬品の開発は,製薬企業と診断薬企業の連携のあり方やそのビジネスモデル,また,コンパニオン診断薬に関連する規制のあり方など,未だ多くの課題が山積している。さらに,臨床現場においても,コンパニオン診断薬としてのlaboratory developed test(LDT)のあり方やコンパニオン診断薬の保険償還など,産官学で議論していくべき課題が多くある。本稿では,診断薬企業の観点から,コンパニオン診断薬の開発から臨床応用における様々な課題について考察する。
目次
Summary
The personalized health care, it is defined as a medical care which provide the optimal therapy for each individual in consideration of a patient's individual difference, such as a genetic background and a physiological state. A companion diagnosis to stratify a patient appropriately is essential for the spread of personalized health care, and it is important that a companion diagnostic reagent used for the companion diagnosis is properly developed and clinically applied. However, as for the development of companion diagnostics and pharmaceuticals that require it, there are still many challenges such as its business model of cooperation of diagnostics companies and pharmaceutical companies, also, the regulations related to companion diagnostics. Furthermore, even in clinical practice, there are many issues such as the way of reimbursement for companion diagnostics and also the handling of laboratory developed test(LDT)as companion diagnostics. These are issues that should continue to discuss with industry, government and academia. In this report, from the point of view of a diagnostics company, we discuss the various challenges in clinical applications from the development of companion diagnostics.
要旨
個別化医療とは,遺伝的背景や生理的状態など患者の個人差に考慮して各個人に最適な治療法を提供する医療と定義される。個別化医療の普及には,患者を適切に層別化するためのコンパニオン診断が不可欠であり,そのコンパニオン診断に用いられるコンパニオン診断薬が適切に開発,臨床応用されていくことが重要である。しかしながら,コンパニオン診断薬とそれを必要とする医薬品の開発は,製薬企業と診断薬企業の連携のあり方やそのビジネスモデル,また,コンパニオン診断薬に関連する規制のあり方など,未だ多くの課題が山積している。さらに,臨床現場においても,コンパニオン診断薬としてのlaboratory developed test(LDT)のあり方やコンパニオン診断薬の保険償還など,産官学で議論していくべき課題が多くある。本稿では,診断薬企業の観点から,コンパニオン診断薬の開発から臨床応用における様々な課題について考察する。