2022 Volume 39 Issue 4 Pages 495-499
Comprehensive Cancer Genomic Profiling (CGP) tests were launched into clinical practice in Japan since June 2019 under health insurance coverage in two types of CGP tests (OncoGuide™ NCC Oncopanel System and FoundationOne CDx). In August 2021, FoundationOne Liquid CDx was also launched as a liquid biopsy, analyzing circulating tumor DNA by serum.
Ministry of Health, Labour and Welfare (MLHW) has designated 12 core hospitals, 33 base hospitals, and 189 cooperative hospitals for CGP tests under health insurance in Japan (as of April 2022). The eligibility criteria for CGP tests includes only patients who (almost) finished all the standardized treatment with incurable diseases. Therefore, genome–matched therapies may be difficult due to the poor general condition, even when actionable mutations are detected and specific clinical trials are recommended. In C–CAT (Center for Cancer Genomics and Advanced Therapeutics) database, only 8.1% (607/7,467) received genomically matched treatment. Therefore, more clinical trials are warranted to expand the CGP–based therapies. As germline variants are also detected by CGP test, as well as somatic variants, specific to cancer tissues, genetic counseling is often required to appropriately assess the possibility of hereditary diseases. As whole–genome analysis is ongoing in many solid tumors, establishment of genetic counseling in each hospital is also important to address various types of germline findings.
