The government has decided to include direct-to-consumer genetic testing in the “regulatory sandbox,” a scheme to remove or postpone regulations to help companies provide new products or services.
Direct-to-consumer genetic testing allows a non-medical institution to give consumers direct access to their genetic information.
The government’s decision raises a chance to make an additional 13 diseases, including coronary artery disease, prostate cancer, and Parkinson’s disease, eligible for the direct-to-consumer genetic testing. Currently, the government allows such testing to cover only 12 indications such as abnormal body mass index and hair loss.
The Ministry of Trade, Industry, and Energy said on Monday that it passed four agendas to be deregulated at the first committee meeting on deliberating special cases of regulations. The four includes installing urban hydrogen-fueling stations and providing genome analysis to enhance health.
The ministry allowed “demonstration exception,” a system that allows testing in a limited area, period, and scale to verify the safety of a new product or service before the commercialization, despite the existing regulations.
|President Moon Jae-in (fourth from left, left row) chairs a meeting to discuss ways to attain innovative growth through regulatory reforms, at Cheong Wa Dae Monday.|
The government also granted a “temporary approval” system to give a provisional permit for a market release of a new product or service, already verified in safety, and confer official license later.
Biotech firm Macrogen requested the government to expand items for direct-to-consumer genetic testing.
The company applied for the demonstration exception on its service to recognize the possibility of disease development and prevent it through individual genome analysis.
The government had restricted direct-to-consumer genetic testing only to 12 items -- body mass index, triglyceride concentration, cholesterol, blood sugar, blood pressure, pigmentation, hair loss, hair thickness, aging, skin elasticity, vitamin C concentration, and caffeine metabolism.
Additionally, Macrogen applied for the demonstration exception on 15 diseases – six chronic diseases (coronary artery disease, atrial fibrillation, hypertension, type-2 diabetes, stroke, osteoarthritis), six common cancer (prostate cancer, colorectal cancer, stomach cancer, lung cancer, liver cancer, breast cancer), and three geriatric diseases (macular degeneration, Parkinson's disease, dementia).
However, the government took out the two – breast cancer for and dementia. The government said breast cancer needed additional research on genetic factors and dementia treatment has not been developed yet.
The ministry said it would review whether to grant the exception on late-onset Alzheimer’s later through a meeting with experts.
The demonstration project will be on 2,000 adults living in the Incheon Economic Free Zone for two years for research. The program will take place after a review by the Institutional Review Board.
The results will be open only to the individuals that applied for the testing.
The U.S. approves direct-to-consumer genetic tests on 12 diseases including Parkinson’s disease, Alzheimer’s disease, and colon cancer. Japan and China allow such service on 360 and 300 diseases, respectively, without regulations.