Trends and Challenges of the Statutory Regulation of Molecular Genetic Tests]

Advances in basic science have made it possible to characterize tumors at molecular levels and exploit the differences in the genetic makeup of tumors for personalized cancer treatment. Biomarker tests are essential to stratify patients with the same tumor histology for appropriate treatment. Such tests are developed together with drugs, involving mainly molecular genetic tests at present, and are called companion diagnostics (CDx). Under the universal health care system in Japan, molecular genetic tests are permitted in clinics, and the fees are reimbursed only when approved diagnostic reagents or kits are used. However, new tests are developed so fast that the regulation cannot keep up with the pace. To fill this gap, the framework of advanced medical technologies was introduced in 1984. In 2012, this framework was amended to classify medical technology using unapproved diagnostics or home-brew assays as advanced medical technologies A. In my talk at this symposium, trends and challenges of the statutory regulation of molecular genetic tests in Japan were discussed, followed by personal proposals to advance the clinical application of novel medical technologies in the field of personalized cancer treatment.