title: [Companion Diagnostics Sub-Section of Anatomic Pathology Department in a Mid-Sized General Hospital: Start Up and Maintenance].
abstract: We introduce the establishment of a companion diagnostics sub-section of an anatomic pathology department in our mid-sized general hospital. Recent cancer pharmacotherapy targets are growth factor receptors and their associated signal transduction molecules. The presence or absence of mutations in these genes influences the effects of drugs on an individual tumor. Gene polymorphisms of anti-cancer drug metabolism-related enzymes are also closely associated with severe toxicity. Medical oncologists must have knowledge of gene alterations of growth factor receptors and associated signal transduction molecules and polymorphisms of anti-cancer drug metabolism-related enzymes in each case. Large numbers of cases with advanced cancers of the colon/rectum or lung are admitted to our mid-sized general hospital. Analyses of KRAS and EGFR gene mutations and UGT1A1 polymorphisms should be performed within an anatomic pathology department, in order to obtain results of genetic analysis and start tailor-made pharmacotherapy as soon as possible. Cost performance is not low. Executive members of the hospital decided to establish a new hospital which will focus on cancer surgery and pharmacotherapy, and it is scheduled to be completed in one year, next to the present building. So we, including the head of medical technologists, immediately proposed the start up of a companion diagnostics sub-section in an anatomic pathology department. The executive members agreed with our proposal, and purchased a fully-automated genotyping system, IS-5320 (idensy IS-5320 ARKRAY). Companion diagnostics regarding molecular targeting pharmacotherapy should be performed even in a mid-sized general hospital.
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Nakayama
authors.forename: Mayumi
authors.initials: M
authors.lastname: Yasuhara
mesh_terms: D005820:Genetic Testing; D005838:Genotype; D006769:Hospitals, General; D006801:Humans; D017056:Medical Laboratory Personnel; D009154:Mutation / Q000235:genetics; D011110:Polymorphism, Genetic / Q000235:genetics