2018 Volume 8 Issue 2 Pages 83-94
Gene-testing technology has dramatically advanced in recent years, and it now provides a simple and relatively affordable way to test the genetic makeup of individuals. In addition to genetic testing at medical institutions, companies now provide a DTCGT (Direct-to-Consumer Genetic Testing) system, which allows consumers to undertake a genetic test directly without visiting a medical institution, resulting in an expansion of the available services that predict potential diseases. Today, most DTCGT tests are not performed under the supervision of a registered physician or trained medical professional, which is both a medical and an ethical issue, and there is no suitable established regulation for DTCGT testing. Here we compare genetic testing rules and regulations in Japan, the U. S. and Europe (the UK, Germany, and France). We note that there are established laws and regulations governing the DTCGT system in most western countries, whereas in Japan there is guidance but no rules or regulations. To clarify the current situation in Japan, we surveyed the organizations that use the DTCGT system both in person and over the internet. We found that most of the 112 organizations using the system did so without supervision of a registered physician or trained medical professional supervision. We also identified genetic-testing results diagnosing disorders that actually needed suitable medical gene counseling. We conclude that the timely implementation of appropriate laws and regulations is necessary to solve these issues arising from the rapid expansion of DTCGT use in Japan.
