[Entangled Genetic Industry]③ "DTC Testing Increasingly Important for Health Management"

Interview with Choi Dae-chul, Chairman of the Genome Enterprise Council

Innate physical information can be known through DTC testing
Promoting healthy lifestyle habits
"However, regulations remain... We will strive to ease them"

"As people can now know their innate physical information, direct-to-consumer (DTC) genetic testing is becoming increasingly important because it can encourage healthy lifestyle habits. During my term, I will meet with the government, medical community, and industry to ensure the steady growth of the domestic DTC genetic testing industry."

Choi Dae-chul, Chairman of the Genome Enterprise Association

Choi Dae-chul, chairman of the Genome Companies Council and CEO of NGENBIO, who will lead the council starting in September, recently said in an interview with Asia Economy, "It has been about seven years since DTC genetic testing began in Korea, but there is still much to be done."

Although the DTC genetic testing industry entered the regulatory framework in 2016, it has been difficult to form a proper market due to various regulations surrounding genetics. Asia Economy previously pointed out the 'killer regulations' of the DTC testing industry: the number of testable items is limited compared to the industry's analytical capabilities, the approval process is complicated, secondary use of data is restricted, and testing for adolescents is not allowed.

Regarding this, Chairman Choi emphasized, "At least during my term, I will strive to enable the secondary use of DTC genetic testing information." According to the guidelines for DTC genetic testing services, consumers' genetic test results cannot be used to provide linked secondary service information. For example, this means that a consumer genetically deficient in vitamin C cannot be informed about specific health functional food products suitable for them.

Because of this, the genetic analysis industry, which finds it difficult to collaborate with health-related companies, is said to have a shaky business foundation. The regulatory sandbox pilot project, which allowed bio companies to recommend health functional foods, was not institutionalized and ended last year. Chairman Choi stated, "I will work closely with the Ministry of Health and Welfare to enable the secondary service use of DTC genetic testing."

The domestic DTC genetic testing system is evaluated as being significantly more restricted compared to global standards. While the United States and Japan allow an unlimited number of DTC genetic testing items, Korea permits up to 101 items. Although this is more than nine times the 12 items allowed when the system was first implemented, it is considered very limited compared to the testing capabilities of domestic genetic analysis companies. Ultimately, this is analyzed to cause Korea to fall behind in global competitiveness.

Chairman Choi said, "The genetic industry is greatly influenced by the level of government regulation." He added, "Fortunately, the government has a goal to make the biohealth industry one of the world's top six powers and is paying close attention to regulatory reform measures. I will communicate closely with government officials to ensure that the DTC testing industry does not become half-baked."

The Genome Companies Council under the Korea Bio Association is a consortium of domestic genetic analysis companies established in 2015 to improve regulations on DTC genetic testing. Currently, 28 companies participate. Chairman Choi’s term, elected at last month’s general meeting, is two years. Shin Dong-jik, CEO of Medigen Human Care, serves as vice chairman, and five companies?Theragen Bio, Macrogen, DNA Link, LabGenomics, and AccuGene?are on the steering committee.