■ A statement issued by the Council of Genetic Enterprises

■ Demand for encouragement of innovative services such as wellness

■ Emphasize efforts to self-purify regulatory improvements ahead of the implementation of the DTC certification system this year

"Genetics provide solutions to diagnosis and treatment and become the foundation for innovation in the bio-industry ecosystem. Consumer Direct Request (DTC) genetic testing services could be a conduit for innovation." Hwang Tae-soon, chairman of the Genomic Companies Council under the Korea Bio Association, stressed on the 14th, "We should boldly encourage innovative services to come out in safe areas such as wellness rather than putting excessive regulatory frames on DTC."

Twenty-seven members of the Council of Genome Companies issued a "statement to create a proper DTC genetic testing service ecosystem" and said, "We will contribute to the creation of a healthcare ecosystem and bio-powerful country by making efforts to provide safe DTC services that meet legal guidelines along with regulatory innovation."

Specifically, he worked with the government, medical, legal, and civic groups to create the △ healthcare ecosystem to encourage the provision of high-quality services within the △ DTC certification system and to comply with the △ Personal Information Protection Act. In addition to urging the government to improve regulations, it emphasized the need to create a sound ecosystem and the industry's willingness to self-purify ahead of the implementation of the DTC certification system this year.

DTC genetic testing refers to a test conducted by a consumer directly requesting a genetic testing agency without going through a medical institution. It has a net function of predicting the risk of individual diseases and preventing diseases by improving lifestyle habits. It is also considered the best healthcare service in the non-face-to-face era. More than 10 companies entered the market as services became possible in Korea in 2016 due to the revision of the Bioethics Act, but the industry was slow to revitalize due to opposition from the medical community and higher regulatory strength than advanced countries. The issue of equity with overseas companies that provide services without item restrictions has also continued to emerge as they are not subject to domestic regulations.

The number of test items, which were limited to 12 including skin, hair loss, and blood pressure, will increase to 70 through a pilot project, and a DTC gene test institution certification system will be implemented this year that allows certified companies to add test items after deliberation by a separate review committee.

However, medical tests such as disease diagnosis are still not allowed. In addition, every time an inspection item is added, it must be reviewed, and if the review committee is formed around the medical community, there is room for it to act as another regulation. In addition, DTC services can lead to service innovation such as personalized diet, exercise solutions, and drug prescriptions only when they collaborate with heterogeneous fields, but there are concerns that it will be difficult to expand the market if the meaning of DTC is limited to deliver sales and test results.

CEO Samuel Hwang said, "Based on scientific and medical clues provided by genes, hospitals, examination centers, food companies, and exercise management companies need to create innovative killer applications such as diagnosis, treatment, and healthcare."