Regulated sandbox and disease-related genetic tests as a direct-to-consumer test
10.5124/jkma.2019.62.5.240
- Author:
Jong Won KIM
1
Author Information
1. Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. kimjw@skku.edu
- Publication Type:Editorial
- Keywords:
Genetic test;
Direct-to-consumer test;
Regulated sandbox
- MeSH:
Chronic Disease;
Genetic Testing;
Korea
- From:Journal of the Korean Medical Association
2019;62(5):240-242
- CountryRepublic of Korea
- Language:Korean
-
Abstract:
Recently, the Korean government introduced a regulatory sandbox that includes direct-to-consumer (DTC) genetic tests. Several genetic testing companies received approval for predictive DTC genetic tests for conditions ranging from cancer to chronic diseases. However, it is not evident how DTC tests should be carried out and interpreted. It does not seem to estimate the accuracy of the predictive genetic testing from a two-year exemption trial. However, clinical laboratories can no longer explore innovative approaches to genetic testing because of the restrictive regulatory and legal environment. Genetic testing companies can provide DTC services without restrictions on facilities, equipment, and personnel although those testing services were not fully supported scientifically. Present situation in Korea on DTC genetic test should be reformed.
