The Regulatory Gap for Preimplantation Genetic Diagnosis
The Regulatory Gap for Preimplantation Genetic Diagnosis
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DOI：
10.1002/hast.412
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发表时间：
2015-01-01
影响因子：
3.3
通讯作者：
Bayefsky, Michelle
中科院分区：
文献类型：
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作者：
Bayefsky, Michelle
植入前遗传学诊断是在生育治疗中根据基因选择胚胎的强大技术，目前在美国不受监管，这与几乎所有其他可以使用PGD的国家不同。当然，基因检测的分析质量、进行检测的实验室和执行检测的技术人员都要遵守《临床实验室改进修正案》的要求。由于食品和药物管理局准备开始规范实验室开发的测试，包括许多基因测试，这些测试的临床有效性可能也需要得到证明。但是CLIA和美国食品和药物管理局都不负责管理医疗实践，州法律和相关的医学协会在何时以及为什么应该进行PGD的问题上基本上保持沉默。这一监管空白的结果是，尽管PGD最初是用于筛选胚胎的严重遗传性疾病，但它现在也被用于各种更具争议性的目的。
The use of preimplantation genetic diagnosis, the powerful technique employed during fertility treatment to select embryos based on their genes, is currently unregulated in the United Statesunlike in nearly all other countries where PGD is available. Of course, the analytical quality of the genetic tests, the laboratories where they are performed, and the technicians who carry them out are subject to the Clinical Laboratory Improvement Amendment requirements. And as the Food and Drug Administration prepares to begin regulating laboratory-developed tests, including many genetic tests, the clinical validity of the tests may also need to be demonstrated. But neither CLIA nor the U.S. Food and Drug Administration is responsible for governing medical practice, and state law and the relevant medical associations have largely fallen silent on the questions of when and why PGD ought to be performed. The result of this regulatory lacuna is that while PGD was originally intended for screening embryos for severe heritable disorders, it is now also employed for a variety of more controversial purposes.