title: [Issues of Personalized Medicine from the Viewpoint of Laboratory Medicine].
abstract: Personalized medicine is expected to provide patients with safe and effective treatment compared to conventional medical care in which patients are treated based on the diagnosis and/or histology. In personalized medicine, patients are treated based on their genetic makeup and genetic characteristics of tumor tissues in the case of cancer chemotherapy. Genomic biomarker tests are used to molecularly characterize host and tumor tissues and stratify patients for the appropriate drugs. Drugs targeting the causative genetic changes have been developed along with companion diagnostics to test such genetic changes. In this paper, I introduce the technical guidance for companion diagnostics and related drugs issued by the Pharmaceutical and Medical Devices Agency of Japan, and discuss how to carry out a concordance study of diagnostic tests for the ALK fusion gene when new ALK inhibitors are approved. The regulations for companion diagnostics should be revised frequently to keep up with advances in this area.
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Nobori
mesh_terms: D000077548:Anaplastic Lymphoma Kinase; D005820:Genetic Testing; D006801:Humans; D007348:Insurance, Health; D057285:Precision Medicine; D020794:Receptor Protein-Tyrosine Kinases / Q000032:analysis
chemical_list: C000626173:ALK protein, human; D000077548:Anaplastic Lymphoma Kinase; D020794:Receptor Protein-Tyrosine Kinases