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.

Media portrayal of non-invasive prenatal testing: a missing ethical dimension

“…We analyze the media discourse from January 1, 2013 to December 31, 2013 -a one-year period marked by a significant in-take of NIPT clinical services in North America, Europe, and the Asia-Pacific region, as well as a rapid growth of the global NIPT market [Transparency Market Research, 2015]. Given the emphasis on intellectual property (IP) and commercialization issues in the emerging debate on NIPT [Agarwal et al, 2013], we considered important to scrutinize how NIPT was portrayed in both the popular press and industry news publications. The major objective of our analysis of media coverage hence was to establish major themes and dominant frames in media representations across different news sources that may shed light on the social context of discourse on this controversial technology.…”

“…Historically pre-natal screening has been routinely used for sex selection and has contributed to widespread gender discrimination in developing nations such as India, China and Brazil, but also in developed countries such as the U.S.A. and Hungary [Wertz and Fletcher, 1993;George, 2006]. Fourth, the cost of NIPT and the fact that it is entering the healthcare system through the private market raise concerns about just and equitable access to the test [Agarwal et al, 2013]. The final set of considerations includes legal arguments regarding the current trend of patenting NIPT technologies as limiting access to the test [Norton, Rose and Benn, 2013], as well as the possible liability of clinicians who do not offer NIPT to pregnant women and their exposure to 'wrongful life' or 'wrongful birth' claims [Toews and Caulfield, 2014].…”

Non-invasive prenatal testing (NIPT): limitations on the way to become diagnosis

“…In Table 3, the special characteristics of the four available US-based NIPT that have dominated the worldwide market are summarized [32,63]. All these tests are performed in CAP-accredited and CLIA-certified commercial laboratories.…”

Current status of non-invasive prenatal testing (NIPT): genetic counseling, dominant methods and overall performance

“…The concept behind trisomy testing with cffDNA is based on the observation, that a fetus with trisomy 21 contributes a higher proportion of chromosome 21 specific cffDNA fragments into the total cell-free DNA pool than a non trisomic fetus. By using next generation sequencing (NGS), this marginal difference in cfDNA amount can be reliably detected, which led to the commercial introduction of non-invasive trisomy 21 testing in the U.S. in 2011 [5]. Since that time, the number of commercial non-invasive prenatal testing (NIPT) providers and NIPT validation studies increased enormously.…”