Direct to customer (DTC) genetic testing companies are expanding their testing areas to diseases and diverse wellness fields on the back of the government’s “sandbox” deregulation initiative.
The Ministry of Trade, Industry, and Energy designated three additional companies, DNA Link, Theragen Etex and Medizen Humancare, as DTC genetic testing companies on April 29.
As a result, a total of four genetic testing companies, including Macrogen, which was selected as the first beneficiary of the deregulation initiative, will apply DTC genetic testing to disease prevention, which was not possible within the current regulatory framework.
Currently, Korea permits genetic testing agencies, which are not a medical institution, to carry out genetic testing for only 12 items, including body mass index and hair loss. They are not allowed to use genetic testing for any disease-related items. Although the testing approved within the regulatory sandbox is limited to research purposes, the companies can nevertheless improve customer service based on customer feedback and expand their business to overseas markets.
Macrogen, which received approval in February, plans to carry out a customized health promotion service through DTC genome analysis on 13 diseases for 2,000 adults in the Incheon Free Economic Zone for two years. The 13 diseases include six chronic diseases, including coronary artery disease and atrial fibrillation, five carcinogenesis, including prostate cancer and colorectal cancer, and two geriatric diseases, including Parkinson's disease. The company plans to carry out the testing from the second half of the year.
DNA Link was approved for a total of 32 items, including six types of cancer, 14 diseases and 12 types of wellness (excluding 12 types of existing DTCs). The company will carry out the testing for 2,000 applicants at the Dementia Prevention Center in Gwangju Metropolitan City.
Medizen Humancare was approved for 13 items related to athletic ability, such as kinesthetic ability, exercise drive, and heart rate recovery. The company plans to conduct a study on a total of 2,800 people, including students from the College of Physical Education of Kyunghee University and Konkuk University, people who were diagnosed with obesity in the hospital and the general public.
In particular, the company is preparing for the exercise genome analysis project through Sichuan Biological Technologies Limited., a joint venture it established with the China Athletic Association. As a part of the training program for professional athletes, it aims to analyze the genes related to the athletic ability of Chinese athletes.
Meanwhile, Theragen Etex has been granted approval for 24 items in the wellness field, including obesity and nutrition management. It plans to develop its products by matching the differentiated solutions based on the results of genetic testing in each field.