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Federal Regulation of Genetic Testin Neglect

机译:联邦基因检测疏忽条例

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U.S. consumers generally take for granted that the government assesses the safety and effectiveness of drugs and other medical products before they are made available commercially. But for genetic tests, this generally is not the case. At the same time, the number and type of genetic tests continue to increase, and tests for more than 900 genetic diseases are now available clinically. Genetic testing is playing a growing role in health care delivery and is providing information that can be the basis for profound life decisions, such as whether to undergo prophylactic mastectomy, terminate a pregnancy, or take a particular drug or dosage of a drug. Current gaps in the oversight of genetic tests, and of the laboratories that offer them, thus represent a real threat to public health.
机译:美国消费者通常认为政府在对药物和其他医疗产品进行商业销售之前会评估其安全性和有效性。但是对于基因检测,情况通常并非如此。同时,基因检测的数量和类型继续增加,现在临床上可以检测900多种遗传疾病。基因测试在医疗保健服务中发挥着越来越重要的作用,并且提供的信息可以作为做出深刻人生决定的基础,例如是否进行预防性乳房切除术,终止妊娠或服用某种药物或某种剂量的药物。因此,目前对基因检测以及提供这些检测的实验室的监督存在空白,这对公共卫生构成了真正的威胁。

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