Example of a test result report from Teragen Bio, a DTC genetic testing company <Provided by Teragen Bio>

Example of a test result report from Teragen Bio, a DTC genetic testing company

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[Asia Economy Reporter Choi Dae-yeol] It is now possible to undergo genetic testing at private genetic testing institutions for the effects of weight loss through exercise and the so-called yo-yo effect of weight regain after weight loss.


The Ministry of Health and Welfare recently revised the "Regulations on Genetic Testing That Can Be Conducted Directly by Genetic Testing Institutions, Not Medical Institutions" (Ministry of Health and Welfare Notice) to increase the number of allowable direct-to-consumer (DTC) genetic testing items to a maximum of 70. Previously, there were 56 items.


This revised notice reflects the rapid evaluation results for four companies that passed the first pilot project last year as part of the second pilot project for the introduction of the DTC genetic testing service certification system currently underway this year. Macrogen, Theragen Bio, and LabGenomics passed, and the number of DTC genetic testing items each company can perform has increased to 70.


In addition to the previous 56 items, newly added items include nine in the nutrient category such as vitamin A, and four in the health management category such as bone mass and abdominal obesity. Some items were conditionally approved with supplementary explanatory statements provided to consumers when delivering results. The Ministry of Health and Welfare stated that the expanded DTC genetic testing will be managed on the condition of re-evaluating the predictive accuracy of test items after two years, periodic blind assessments, consumer satisfaction surveys, and preparation of personal information protection measures.



The revised notice also clarified the responsibilities of testing institutions. It specifies that under the responsibility of the testing institution, activities such as specimen collection, testing, analysis and delivery of test results, as well as explanation, information provision, and obtaining consent from consumers, must be conducted.


This content was produced with the assistance of AI translation services.

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