Approval gap of pharmacogenomic biomarkers and in vitro companion diagnostics between the United States and Japan

is known and objectives: In vitro companion diagnostic devices (CDx) provide information on pharmacogenomic bio-markers (PGBMs) to enable the safe and effective use of targeted agents for personalized therapy. These devices require specific regulations that strike a balance between scientific evidence and financial burden. The aims were to compare approval of PGBMs and CDx in the USA and Japan and to help inform current discussions on personalized medicine. Methods: We analysed published documentation from the USA and Japan for CDx and PGBMs, listed by the US Food and Drug Administration (FDA). Aspects evaluated were aim, approval state and therapeutic area. Coverage by the National Health Insurance in Japan was also investigated. Results and discussion: Thirty-eight PGBMs were listed in the FDA table as of March 2013. In the USA, the aim was efficacy i