The review of the concept of genetic testing that is necessary for surgeons in Japan

Abstract

Genetic testing is classified into three categories as nucleic acids testing of infectious diseases, somatic and germline genes testing. From the experiences of genomic testing on COVID-19, the importance of accuracy and standardization of PCR testing were re-recognized. The third-party accreditation of laboratory medicine is beneficial for the improvement of the analytic validity of the genomic and precision medicine such as comprehensive cancer gene panel tests（CGP tests）. The genetic testing of incurable diseases and reproductive technics will be shortly supported by public health insurance. The necessity of the proficiency testing（PT）and external quality assessments（EQA）for tumor genetic testing using clinical samples as well as standard reference materials is important. The clinical data sharing system based on the companion diagnostics（CDx）is indispensable for the precision medicine. Further, the bringing up by the on-the-job training of the staffs including surgeons in the hospital are necessary to promote the genomic and precision medicine in Japan. To establish the system of PT/EQA for laboratory developed tests（LDTs）is essential for genomic and precision medicine via the experience of SARS-CoV-2 detection in Japan. This review described the minimal essence and concept of genetic testing that is necessary for surgeons in Japan.