Direct To Consumer(DTC) genetic testing, which was available only for 12 items and 46 genes such as blood sugar, blood pressure, hair loss, and vitamin C, will be permitted without restrictions up to 56 items (wellness) in the areas of kinetic compatibility, alcohol flush, and genealogy searches for the next 2 years.
However, the target institutions are only 4 companies that have received quality control certification from the Ministry of Health and Welfare's pilot project, Labgenomics, Macrogen, Eone Diagnomics Genome Center(EDGC), and Theragen Etex. This is on a temporary permission basis for 2 years only, and the permission will be revisited after reviewing the examination accuracy improvement rates.
The 5th National Bioethics Committee, the president's highest deliberation agency on national bioethics and safety policies, made its decision on the 18th at its third meeting.
At the second meeting in December last year, the Committee agreed that quality control and appropriate inspection(monitoring) of DTC genetic testing services are necessary for the public's right to know and safety.
The Ministry of Health and Welfare conducted a pilot project for DTC genetic testing service for 57 wellness items and reported the assessment and certification results. Twelve companies participated in the pilot project, seven of which formally participated, and five did not meet the criteria for participation in the pilot project, but was allowed to participate for testing and training purposes.
As a result, four companies such as Labgenomics, Macrogen, EDGC, and Theragen Etex passed the on-site evaluation and showed excellent inspection accuracy rate of nearly 100% and was assessed almost to the certified level.
The Committee thinks that the examination items need to be expanded on a limited basis based on the result of the certification pilot project for ensuring the service quality of the DTC genetic examination and appropriate monitoring.
In this process, to secure the public safety and right to know of the public, it was recommended that strong monitorning·management be implemented to the companies that are recognized with its examination capabilities to guarantee the examination result accuracy and the public safety.
Separately, the Committee advised the strong management of a few reported issues ➀DTC genetic testing that is not allowed in Korea to be conducted in foreign countries and the test results be delivered to domestic customers, ➁The use of genetic test results for insurance and marketing purposes that are prohibited by the Bioethics Act.