ファーマコゲノミクス検査の運用指針

A guideline for good practice of pharmacogenomic testing

　日本臨床検査標準協議会は，日本臨床検査医学会遺伝子委員会が作成した「ファーマコゲノミクス検査の運用指針」について，日本人類遺伝学会などの関連学会の意見調整を行い，2009年4月に公表した．本指針の取り扱う範囲は，生殖細胞系列のDNAに反映された情報を対象とする．内容は，既存の関連指針を踏まえつつ，診療現場の実情に即した運用指針で，①検査実施時のインフォームド・コンセント，②検査前後の説明，③個人の遺伝情報の保護，④検査に用いた生体試料（検体）の取扱いについて，の4項目からなる．

In April 2009, Japanese Committee for Clinical Laboratory Standards (JCCLS) issued "A guideline for good practice of pharmacogenomic testing" by means of coordinating discussion among associated academic societies including Japanese Society of Human Genetics.　It has been drafted for a practical use as well as in compliance with applicable existing guidelines.　The recommendations address laboratory and clinical practices on molecular-genetic testing based on germline cell information, and include informed consent, pre- and post-analysis testing guidance, confidentiality of patient information and secondary use of tested specimens.