Malinowski M J
Widener University School of Law, USA.
Jurimetrics. 2000 Fall;41(1):23-52.
This article explores the extent to which completion of maps of the human genome, coupled with the introduction of technology that will accelerate the identification of gene and protein function, have introduced immeasurable potential to advance life science and health care through genetic profiling. In light of definitional uncertainty, the regulatory and legal environment surrounding predictive genetic testing threatens to impede clinical utilization of genetic profiling technologies that could significantly improve human health. Especially given that genetic testing technologies have been stigmatized in the public and medical community, they must enter the marketplace with a regulatory framework that assures safety, efficacy, and market responsibility.
本文探讨了人类基因组图谱的完成，以及加速基因和蛋白质功能鉴定的技术的引入，在多大程度上通过基因轮廓分析为推进生命科学和医疗保健带来了不可估量的潜力。鉴于定义的不确定性，围绕预测性基因检测的监管和法律环境可能会阻碍基因轮廓分析技术的临床应用，虽然这些技术能够显著改善人类健康。特别是考虑到基因检测技术在公众和医学界已被污名化，它们必须在一个确保安全、有效和市场责任的监管框架下进入市场。
