Faculty of Law, School of Public Health, University of Alberta, Edmonton, Alberta, Canada.
Clin Genet. 2010 Feb;77(2):101-5. doi: 10.1111/j.1399-0004.2009.01291.x. Epub 2009 Nov 21.
A wide variety of genetic tests are now being marketed and sold in direct-to-consumer (DTC) commercial transactions. However, risk information revealed through many DTC testing services, especially those based on emerging genome wide-association studies, has limited predictive value for consumers. Some commentators contend that tests are being marketed prematurely, while others support rapid translation of genetic research findings to the marketplace. The potential harms and benefits of DTC access to genetic testing are not yet well understood, but some large-scale studies have recently been launched to examine how consumers understand and use genetic risk information. Greater consumer access to genetic tests creates a need for continuing education for health care professionals so they can respond to patients' inquiries about the benefits, risks and limitations of DTC services. Governmental bodies in many jurisdictions are considering options for regulating practices of DTC genetic testing companies, particularly to govern quality of commercial genetic tests and ensure fair and truthful advertising. Intersectoral initiatives involving government regulators, professional bodies and industry are important to facilitate development of standards to govern this rapidly developing area of personalized genomic commerce.
现在,各种基因检测都在以直接面向消费者(DTC)的商业交易形式进行营销和销售。然而,通过许多 DTC 检测服务揭示的风险信息,特别是基于新兴的全基因组关联研究的服务,对消费者的预测价值有限。一些评论员认为这些检测被过早地推向市场,而另一些人则支持将基因研究成果迅速推向市场。DTC 获得基因检测的潜在危害和益处尚未得到很好的理解,但最近已经开展了一些大规模的研究,以研究消费者如何理解和使用遗传风险信息。消费者更方便地获得基因检测,这就需要对医疗保健专业人员进行继续教育,以便他们能够回应患者对 DTC 服务的益处、风险和局限性的询问。许多司法管辖区的政府机构正在考虑监管 DTC 基因检测公司的做法的选择方案,特别是为了规范商业基因检测的质量,并确保公平和真实的广告。涉及政府监管机构、专业机构和行业的跨部门举措对于制定管理这一日益发展的个性化基因组商务领域的标准非常重要。