The government said it has allowed four companies, including Theragen Etex and Eone Diagnomics Genome Center (EDGC), to provide up to 56 direct-to-consumer (DTC) genetic testing services.
The presidential National Bioethics Committee decided so at a meeting on Wednesday to review the result of the pilot project for the DTC genetic testing service certification system and discuss measures to enhance monitoring.
Earlier in May, the Ministry of Health and Welfare selected 12 institutions that will participate in the pilot project and evaluated their testing abilities for six months through on-site inspection and accuracy assessment. Among them, five were underqualified but joined the project for a trial and to receive education, and the rest seven received the review for business purposes.
The government finally picked four companies as the final participants for the pilot project. The four passed the on-site evaluation and showed nearly 100- percent accuracy in their testing services. They are Theragen Etex, EDGC, Macrogen and LabGenomics.
From next year, the four companies can provide DTC genetic testing services for up to 56 items in the wellness category, including vitamin D, fitness, and alcohol and nicotine metabolism, for two years. Theragen Etex and EDGC applied services for 56 items, respectively, Macrogen, 27, and LabGenomics, 10.
However, the government said the latest expansion of the testing items was not permanent.
Companies should prepare an estimated accuracy of the expanded items, a periodic blindness evaluation (evaluation of the same person's DTC genetic testing by several institutions to check the consistency of the results), a customer satisfaction survey, and a personal information protection plan, and submit them for a review two years later. Based on this data, the committee will assess the appropriateness of conducting the tests.
The health and welfare ministry is likely to maintain its stance that only companies that have undergone rigorous certification assessments have the opportunity to expand items for DTC genetic testing services. The ministry will recruit institutions that wish to get certification for more items next year. Those who have already received the certification can take a shortened procedure to add items.
The government warned that it would impose tough sanctions against those that conduct DTC genetic tests abroad or abuse genetic test results.
“Recently, some people conducted locally non-available DTC geniting testing overseas and delivered the results to local consumers via agents or utilized the testing results in insurance policy subscription and marketing, against the Bioethics Act. The government needs a strong measure against those cases that disrupts the market,” the committee said.
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