Commercial landscape of noninvasive prenatal testing in the United States.

Commercial landscape of noninvasive prenatal testing in the United States.
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DOI:
10.1002/pd.4101
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发表时间:
2013-06
期刊:
影响因子:
3
通讯作者:
Chandrasekharan, Subhashini
Chandrasekharan, Subhashini
中科院分区:
医学2区
文献类型:
--
作者:
Agarwal, Ashwin;Sayres, Lauren C.;Cho, Mildred K.;Cook-Deegan, Robert;Chandrasekharan, Subhashini

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无细胞胎儿DNA为基础的无创性产前检测(NIPT)可以显着改变产前检测和筛查的模式。知识产权(IP)和商业化有望成为有关这些技术临床实施的新兴辩论的重要组成部分。我们从行业新闻、新闻文章以及科学、法律的和商业出版物中收集了有关测试类型、价格、周转时间和最近在美国启动的商业测试的报销的信息。我们还描述了这些测试的基础技术的专利和许可景观和正在进行的专利诉讼在美国。最后,我们讨论了知识产权问题如何影响NIPT的临床翻译及其对利益相关者的潜在影响。胎儿医学专业人员(临床医生和研究人员),遗传咨询师,保险公司,监管机构,测试开发人员和患者可能能够使用这些信息,对当前和新兴的无创产前测试的临床实施做出明智的决定。
Cell-free fetal DNA-based noninvasive prenatal testing (NIPT) could significantly change the paradigm of prenatal testing and screening. Intellectual property (IP) and commercialization promise to be important components of the emerging debate about clinical implementation of these technologies. We have assembled information about types of testing, prices, turnaround times and reimbursement of recently launched commercial tests in the United States from the trade press, news articles, and scientific, legal, and business publications. We also describe the patenting and licensing landscape of technologies underlying these tests and ongoing patent litigation in the United States. Finally, we discuss how IP issues may affect clinical translation of NIPT and their potential implications for stakeholders. Fetal medicine professionals (clinicians and researchers), genetic counselors, insurers, regulators, test developers and patients may be able to use this information to make informed decisions about clinical implementation of current and emerging noninvasive prenatal tests.
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