Regulated sandbox and disease-related genetic tests as a direct-to-consumer test

Article information

J Korean Med Assoc. 2019;62(5):240-242

Publication date (electronic) : 2019 May 17

doi : https://doi.org/10.5124/jkma.2019.62.5.240

Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea

Corresponding author: Jong-Won Kim E-mail: kimjw@skku.edu

Received 2019 May 09; Accepted 2019 May 10.

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.

Keywords: Genetic test; Direct-to-consumer test; Regulated sandbox

References

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Article information Continued

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