title: [Companion Diagnostics for Solid Tumors].
abstract: Companion diagnostics (CoDx) will likely continue to rapidly increase in number and application to disease areas including solid tumors, for example EGFR for gefitinib and ALK fusion gene for crizotinib in non-small-cell lung cancer; KRAS against the use of cetuximab and panitumumab in colorectal cancer; HER2 for trastuzumab in breast cancer. CoDx are an indispensable part of personalized medicine and pharmacogenomics. In CoDx development, there are still many challenges, such as the business model promoting cooperation between diagnostics and pharmaceutical companies, and also the regulations related to CoDx. The FDA notice on the development of CoDx in 2011 recommended the co-development of a new drug and CoDx as the best practice, and the Ministry of Health, Labour and Welfare in Japan also issued a statement in 2013. In addition, the recent discovery of many novel variants in the DNA sequence, advances in sequencing and genomic technology, and improved analytic methods have enabled the impact of germline and somatic mutations to be determined using multiplex diagnosis. The complex challenges to develop CoDx necessitate a close collaboration among academic institutions, regulatory authorities, and pharmaceutical companies. [Review].
authors.forename: Atsushi
authors.initials: A
authors.lastname: Watanabe
mesh_terms: D000077548:Anaplastic Lymphoma Kinase; D014408:Biomarkers, Tumor; D001943:Breast Neoplasms / Q000175:diagnosis* / Q000188:drug therapy / Q000235:genetics; D000068818:Cetuximab / Q000627:therapeutic use; D003110:Colonic Neoplasms / Q000175:diagnosis* / Q000188:drug therapy / Q000235:genetics; D000077547:Crizotinib; D064907:Diagnostic Uses of Chemicals; D055808:Drug Discovery; D066246:ErbB Receptors; D000077156:Gefitinib; D050939:Gene Fusion / Q000235:genetics; D017408:Guidelines as Topic; D006801:Humans; D008175:Lung Neoplasms / Q000175:diagnosis* / Q000188:drug therapy / Q000235:genetics; D025202:Molecular Diagnostic Techniques; D058990:Molecular Targeted Therapy; D010597:Pharmacogenetics; D057285:Precision Medicine; D016283:Proto-Oncogene Proteins p21(ras) / Q000235:genetics; D011720:Pyrazoles / Q000627:therapeutic use; D011725:Pyridines / Q000627:therapeutic use; D011799:Quinazolines / Q000627:therapeutic use; D020794:Receptor Protein-Tyrosine Kinases / Q000235:genetics; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000235:genetics; D000068878:Trastuzumab / Q000627:therapeutic use
chemical_list: D000077548:Anaplastic Lymphoma Kinase; D014408:Biomarkers, Tumor; D000068818:Cetuximab; D000077547:Crizotinib; D064907:Diagnostic Uses of Chemicals; D066246:ErbB Receptors; D000077156:Gefitinib; D016283:Proto-Oncogene Proteins p21(ras); D011720:Pyrazoles; D011725:Pyridines; D011799:Quinazolines; D020794:Receptor Protein-Tyrosine Kinases; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab; C117307:KRAS protein, human; C000626173:ALK protein, human; C508053:ERBB2 protein, human