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.

*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, Myriad Genetics, gene patent, ethical guideline