ヒト Germline 遺伝子検査の現状と今後の課題(3)

臨床検査会社の取組み : 家族性乳癌・卵巣がんの
易罹患性遺伝子検査を例として

小　路　　　滋*1　権　藤　延　久*2
　　　　　　　　　　　　　　　　　　　　　　
Genetic Susceptibility Testing for Hereditary Breast and Ovarian Cancer
−Approach from a Commercial Clinical Laboratory−

Shigeru SHOJI*1 and Nobuhisa GONDO, MD*2

Genetic testing for hereditary cancers and other common diseases are still considered as the research testing, not for the clinical testing in Japan. One of the major reason of this situation is related to the guidelines regarding the human genetic testing issued successively in the spring of 2001, one by joint work of the eight learned societies and the other by the Japan clinical laboratories association. Both of these guidelines warn the condition of the clinical application of genetic testing after research stage must have the evidence data for clinical utility.
We describe the situation of the genetic testing in the U.S. focusing the social background of increasing breast cancer cases and the contribution of Myriad Genetic Laboratories, Inc. for the genetic testing industry. We also describe the Japanese situation of the genetic testing and problems to be solved before spreading widely.
[Rinsho Byori 50 : 877〜882, 2002]

*1Genetic Testing Business Division, FALCO biosystems, Ltd, Kyoto 606-8357
*2Scientific Advisor, FALCO biosystems, Ltd, Kyoto 606-8357
Part-time Lecture, Hyogo College of Medicine

【Key Words】BRCA1，BRCA2，genetic testing(遺伝子検査)，Myriad Genetics(ミリアド・ジェネティックス)，gene patent(遺伝子特許)，ethical guideline(倫理指針)

*1株式会社ファルコバイオシステムズ遺伝子事業部，*2同顧問，兵庫医科大学非常勤講師(第二外科)(〒606-8357 京都市左京区聖護院蓮華蔵町44-3)

E-mail :sshoji@falco.co.jp