Commercial landscape of noninvasive prenatal testing in the United States

Ashwin Agarwal, Lauren C. Sayres, Mildred K. Cho, Robert Cook-Deegan, Subhashini Chandrasekharan

Research output: Contribution to journalReview articlepeer-review

89 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)521-531
Number of pages11
JournalPrenatal Diagnosis
Volume33
Issue number6
DOIs
StatePublished - Jun 2013
Externally publishedYes

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Genetics(clinical)

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