Table 2.

Use of NGS in the national platform of CGM in Japan

Type of genomic testing	Institution	Type of medical care
Multiplex CDx system (approved as IVD)	Common hospitals or commercial laboratories	Regulatory approval and insurance coverage
Gene Panel testing of clinically relevant genes including genes for which the level of therapeutic evidence is not high (approved as IVD)	CGM hospitals and medical institutions	Regulatory approval and insurance coverage (after advanced medical care is performed, if needed)
Whole‐genome sequencing, and immuno‐oncology testing (non‐IVD)	Performed at medical institutions that meet certain requirements	Combined treatment using advanced medical care that is not covered by insurance

Abbreviations: CGM, cancer genome medicine; IVD, in vitro diagnostics; NGS, next‐generation sequencing.