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J Korean Med Assoc > Volume 62(5); 2019 > Article
Kim: Regulated sandbox and disease-related genetic tests as a direct-to-consumer test

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.

REFERENCES

1. Ministry of Science and ICT. Press release: ICT regulatory sandbox. 2019.1.10. Gwacheon: Ministry of Science and ICT; 2019.

2. Ministry of Trade, Industry and Energy. Press release: 3rd regulatory sandbox committee. 2019.4.29. Sejong: Ministry of Trade, Industry and Energy; 2019.

3. e-Narajipyo. Statistics of cancer death rate and incidence rate in Korea [Internet]. Deajeon: Statistics Korea; 2019. [cited 2019 May 7]. Available from:. http://www.index.go.kr/potal/main/EachDtlPageDetail.do?idx_cd=2770.

4. Song W, Jeon HG. Incidence of kidney, bladder, and prostate cancers in Korea: an update. Korean J Urol 2015;56:422–428.
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5. Kim S, Eom KW, Cho CR, Um TH. Comparison of commercial genetic-testing services in Korea with 23andMe service. Biomed Res Int 2014 Jun 25;[Epub].. https://doi.org/10.1155/2014/539151.
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