This review surveys the developing market for direct-to-consumer (DTC) genetic tests and examines the range of companies and tests available, the regulatory landscape, the concerns raised about DTC testing, and the calls for enhanced oversight. We provide a comparative overview of the situation, particularly in the United States and Europe, by exploring the regulatory frameworks for medical devices and clinical laboratories. We also discuss a variety of other mechanisms such as general controls on advertising and consumer law mechanisms.

中文翻译：

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直接面向消费者的基因测试的现状：法律，道德和政策问题。

这篇评论调查了直接面向消费者（DTC）基因测试的发展中市场，并检查了公司和可用测试的范围，监管范围，对DTC测试提出的担忧以及对加强监督的呼吁。通过探索医疗设备和临床实验室的监管框架，我们对情况进行了比较概述，尤其是在美国和欧洲。我们还将讨论各种其他机制，例如广告的一般控制和消费者法律机制。