TY - JOUR
T1 - Commercial landscape of noninvasive prenatal testing in the United States
AU - Agarwal, Ashwin
AU - Sayres, Lauren C.
AU - Cho, Mildred K.
AU - Cook-Deegan, Robert
AU - Chandrasekharan, Subhashini
PY - 2013/6
Y1 - 2013/6
N2 - 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.
AB - 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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U2 - 10.1002/pd.4101
DO - 10.1002/pd.4101
M3 - Review article
C2 - 23686656
AN - SCOPUS:84878130004
SN - 0197-3851
VL - 33
SP - 521
EP - 531
JO - Prenatal Diagnosis
JF - Prenatal Diagnosis
IS - 6
ER -