Journal
PRENATAL DIAGNOSIS
Volume 33, Issue 6, Pages 521-531Publisher
WILEY
DOI: 10.1002/pd.4101
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Funding
- National Human Genome Research Institute (Duke Center for Public Genomics, a Center for Excellence in ELSI Research grant) [P50 HG 03391-06]
- NIH [P50 HG003389, 1 U54 RR024374-01A1]
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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. (c) 2013 John Wiley & Sons, Ltd.
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