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Ashwin Agarwal, Lauren C. Sayres, Mildred K. Cho, Robert Cook-Deegan and Subhashini Chandrasekharan Commercial landscape of noninvasive prenatal testing in the United States Prenatal Diagnosis 33

Article first published online: 17 MAY 2013 | DOI: 10.1002/pd.4101

What's already known about this topic?

  • Data about technologies underlying cell-free fetal DNA-based noninvasive prenatal tests and their clinical validity are available in scientific publications. Several papers have detailed ethical and practical concerns surrounding noninvasive prenatal testing.
  • Information about the costs, reimbursement, and intellectual property associated with recently launched tests are available but not readily accessible to stakeholders.
  • There has been limited discussion of issues surrounding patenting and commercialization and their effects on clinical translation of noninvasive prenatal testing.

What does this study add?

  • We detail the intellectual property and business landscape of current and emerging noninvasive prenatal tests by bringing together information from trade press, news, legal business, and scientific publications.
  • We also discuss potential effects of patenting and commercialization on the clinical implementation of noninvasive prenatal testing and patient access.

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