title: Commercial landscape of noninvasive prenatal testing in the United States.
abstract: 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.
authors.affiliation: School of Medicine, Duke University, Durham, NC, USA.
authors.forename: Ashwin
authors.initials: A
authors.lastname: Agarwal
authors.forename: Lauren C
authors.initials: LC
authors.lastname: Sayres
authors.forename: Mildred K
authors.initials: MK
authors.lastname: Cho
authors.forename: Robert
authors.initials: R
authors.lastname: Cook-Deegan
authors.forename: Subhashini
authors.initials: S
authors.lastname: Chandrasekharan
mesh_terms: D003132:Commerce; D004247:DNA / Q000097:blood; D005260:Female; D005820:Genetic Testing / Q000191:economics* / Q000331:legislation & jurisprudence / Q000379:methods; D006801:Humans; D018973:Intellectual Property; D011247:Pregnancy; D011296:Prenatal Diagnosis / Q000191:economics* / Q000379:methods; D012732:Sex Determination Analysis / Q000191:economics / Q000379:methods; D014481:United States
chemical_list: D004247:DNA