title: [Discussing the usefulness of companion diagnostics - introductory remarks by chairpersons].
abstract: Personalized medicine has been expected to be utilized in daily practice since the international human genome project completed sequencing of the entire genome in 2003. The aim of personalized medicine is to treat patients effectively and safely based on the genome characteristics of each patient, or to choose the right drug for the right patient at the right time and at the right dose. Regulatory agencies such as the United States Food and Drug Administration(FDA) and Pharmaceuticals and Medical Devices Agency (PMDA), Japan implemented guidance to facilitate the co-development of drugs and companion diagnostics. For the practice of personalized medicine, companion diagnostic tests are essential, although their availability is limited.
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Nobori
authors.forename: Fumio
authors.initials: F
authors.lastname: Nomura
mesh_terms: D003955:Diagnostic Tests, Routine; D007564:Japan; D057089:Pathology, Molecular / Q000379:methods; D010597:Pharmacogenetics / Q000379:methods; D057285:Precision Medicine; D014481:United States; D014486:United States Food and Drug Administration