• Genomics & Informatics
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• 제17권3호
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• pp.34.1-34.3
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• 2019

Direct-to-consumer (DTC) genetic testing is a controversial issue although Korean Government is considering to expand DTC genetic testing. Preventing the exaggeration and abusing of DTC genetic testing is an important task considering the early history of DTC genetic testing in Korea. And the DTC genetic testing performance or method has been rarely reported to the scientific and/or medical community and reliability of DTC genetic testing needs to be assessed. Law enforcement needs to improve these issues. Also principle of transparency needs to be applied.

• 산업경영시스템학회지
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• 제47권3호
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• pp.191-201
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• 2024

The purpose of this study is to identify factors that influence consumers' acceptance intentions towards Direct-to-Consumer (DTC) Genetic Testing service. DTC genetic testing service can be considered in two aspects: the application of new technology in genetic testing customers can directly purchase and the services for receiving the test results customer can't directly analyze. Existing technology-based acceptance models have difficulty fully explaining consumers' acceptance intentions towards DTC genetic testing services. Therefore, this study aims to propose a new acceptance model considering these two characteristics. A survey was conducted with 377 potential consumers for this research. The analysis revealed that health interest, prior knowledge, subjective norms, innovativeness, perceived usefulness, and perceived value affect consumers' acceptance intentions. The results obtained through this study can help establish strategies and marketing plans necessary for the diffusion of services, such as DTC genetic testing services, that combine a new technology and a service. In the long term, the accumulated DTC genetic testing results data can contribute to the development of national genetic information infrastructure and preventive medical applications, as well as improve individuals' quality of life.

• Genomics & Informatics
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• 제12권4호
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• pp.151-155
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• 2014

In November 2013, the US Food and Drug Administration (FDA) sent a warning letter to 23andMe, Inc. and ordered the company to discontinue marketing of the 23andMe Personal Genome Service (PGS) until it receives FDA marketing authorization for the device. The FDA considers the PGS as an unclassified medical device, which requires premarket approval or de novo classification. Opponents of the FDA's action expressed their concerns, saying that the FDA is overcautious and paternalistic, which violates consumers' rights and might stifle the consumer genomics field itself, and insisted that the agency should not restrict direct-to-consumer (DTC) genomic testing without empirical evidence of harm. Proponents support the agency's action as protection of consumers from potentially invalid and almost useless information. This action was also significant, since it reflected the FDA's attitude towards medical application of next-generation sequencing techniques. In this review, we followed up on the FDA-23andMe incident and evaluated the problems and prospects for DTC genetic testing.

• Genomics & Informatics
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• 제17권3호
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• pp.33.1-33.3
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• 2019

• Journal of Genetic Medicine
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• 제4권1호
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• pp.1-5
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• 2007

Unprecedented amount of genetic information being generated from the result of Human Genome Project (HGP) and advances in genetic research is already forcing changes in the paradigm of health and disease. The ultimate goal of genetic medicine is to use genetic information and technology to develop new ways of treatment or even prevention of the disease on an individual level for 'personalized medicine'. Genetics is play ing an increasingly important role in the diagnosis, monitoring and management of common multifactorial diseases in addition to rare single-gene disorders. While wide range of genetic testing have provided benefits to patients and family, uncertainties surrounding test interpretation, the current lack of available medical options for the diseases, and risks for discrimination and social stigmatization may remain to be resolved. However an increasing number of genetic tests are becoming commercially available, including direct to consumer genetic testing, yet public is often unaw are of their clinical and social implications. The personal nature of information generated by a genetic test, its power to affect major life decisions and family members, and its potential misuse raise important ethical considerations. Therefore appropriate genetic counseling is needed for patient to be informed with the benefits, limitations and risks of genetic tests, prior to informed consent for the tests. Physician also should be familiar with the legal and ethical issues involved in genetic testing to tell patients how w ell a particular genetic risk factor relates with likelihood of disease, and be able to provide appropriate genetic counseling. Genetic counseling become a mandatory requirement as global standard for many genetic testing such as prenatal diagnosis, presymtomatic DNA diagnostic tests and cancer susceptibility gene test for familial cancer syndrome. In oder to meet the challenge of genetic medicine of 21 century in korean health care system, professional education program and certification board for medical genetics specialist including non-MD genetic counselors should be addressed by medical society and regulatory policy of national health insurance reimbursement for genetic counseling to be in place to promote the implementation of clinical genetic service including genetic counseling for proper genetic testing.

• 융합보안논문지
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• 제24권2호
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• pp.133-140
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• 2024

이용자가 직접 유전체 검사를 의뢰하는 DTC(Direct-to-Consumer) 유전자검사가 확산되고 있다. 수요 확대에 따라 인증제도를 통한 비 의료기관에 검사자격을 부여하고, 검사항목을 확대하였다. 그러나 제약이 적은 국외 사례와 달리 국내 제도에서는 여전히 질병 검사항목은 제외한다. 기존의 비식별 방식은 유전체 정보의 고유성과 가족 공유성에도 영향을 미쳐 충분한 활용 가능성을 보장하지 못한다. 따라서 본 연구는 서비스 활성화 및 검사 항목 확대를 위한 방안으로 분석과정에 완전동형암호를 적용하여 유전체 정보의 유용성을 보장하되, 유출 우려를 최소화한다. 또한 정보주체의 자기결정권 보장을 위해 Opt-out을 기반한 프라이버시 보존 모델을 제안한다. 이는 유전체 정보보호와 활용 가능성 유지를 목표로 하며, 이용자의 의사를 반영한 정보의 활용 가능성을 보장한다.