title: Non-invasive Prenatal Testing and the Unveiling of an Impaired Translation Process.
abstract: Non-invasive prenatal testing (NIPT) is an exciting technology with the potential to provide a variety of clinical benefits, including a reduction in miscarriages, via a decline in invasive testing. However, there is also concern that the economic and near-future clinical benefits of NIPT have been overstated and the potential limitations and harms underplayed. NIPT, therefore, presents an opportunity to explore the ways in which a range of social pressures and policies can influence the translation, implementation, and use of a health care innovation. NIPT is often framed as a potential first tier screen that should be offered to all pregnant women, despite concerns over cost-effectiveness. Multiple forces have contributed to a problematic translational environment in Canada, creating pressure towards first tier implementation. Governments have contributed to commercialization pressure by framing the publicly funded research sector as a potential engine of economic growth. Members of industry have an incentive to frame clinical value as beneficial to the broadest possible cohort in order to maximize market size. Many studies of NIPT were directly funded and performed by private industry in laboratories lacking strong independent oversight. Physicians' fear of potential liability for failing to recommend NIPT may further drive widespread uptake. Broad social endorsement, when combined with these translation pressures, could result in the "routinization" of NIPT, thereby adversely affecting women's reproductive autonomy. Policymakers should demand robust independent evidence of clinical and public health utility relevant to their respective jurisdictions before making decisions regarding public funding for NIPT.
authors.affiliation: Health Law Institute, Faculty of Law, University of Alberta, Edmonton AB.
authors.forename: Blake
authors.initials: B
authors.lastname: Murdoch
authors.affiliation: School of Public Health, University of Montreal, Montreal QC.
authors.forename: Vardit
authors.initials: V
authors.lastname: Ravitsky
authors.affiliation: Faculties of Law and Pharmacy & Pharmaceutical Sciences, University of Alberta, Edmonton AB.
authors.forename: Ubaka
authors.initials: U
authors.lastname: Ogbogu
authors.affiliation: Centre for Intellectual Property Policy, Faculty of Law, McGill University, Montreal QC.
authors.forename: Sarah
authors.initials: S
authors.lastname: Ali-Khan
authors.affiliation: Centre of Genomics and Policy, McGill University, Montreal QC; UMR 1027, Inserm, Université Toulouse III - Paul Sabatier, Toulouse, France.
authors.forename: Gabrielle
authors.initials: G
authors.lastname: Bertier
authors.affiliation: School of Public Health, University of Montreal, Montreal QC.
authors.forename: Stanislav
authors.initials: S
authors.lastname: Birko
authors.affiliation: School of Public Health, University of Alberta, Edmonton AB.
authors.forename: Tania
authors.initials: T
authors.lastname: Bubela
authors.affiliation: Centre for Law, Technology and Society, University of Ottawa, Ottowa ON.
authors.forename: Jeremy
authors.initials: J
authors.lastname: De Beer
authors.affiliation: School of Public Health, University of Montreal, Montreal QC.
authors.forename: Charles
authors.initials: C
authors.lastname: Dupras
authors.affiliation: Health Law Institute, Faculty of Law, University of Alberta, Edmonton AB; Centre for Law, Technology and Society, University of Ottawa, Ottowa ON.
authors.forename: Meika
authors.initials: M
authors.lastname: Ellis
authors.affiliation: Centre of Genomics and Policy, McGill University, Montreal QC.
authors.forename: Palmira
authors.initials: P
authors.lastname: Granados Moreno
authors.affiliation: Centre of Genomics and Policy, McGill University, Montreal QC.
authors.forename: Yann
authors.initials: Y
authors.lastname: Joly
authors.affiliation: Bachelor of Arts & Science Program, Trent University, Peterborough ON.
authors.forename: Kalina
authors.initials: K
authors.lastname: Kamenova
authors.affiliation: Alden March Bioethics Institute, Albany Medical College, Albany, NY.
authors.forename: Zubin
authors.initials: Z
authors.lastname: Master
authors.affiliation: Health Law Institute, Faculty of Law, University of Alberta, Edmonton AB.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Marcon
authors.affiliation: Faculty of Medicine and Dentistry, University of Alberta, Edmonton AB.
authors.forename: Mike
authors.initials: M
authors.lastname: Paulden
authors.affiliation: Department of Molecular Biology, Medical Biochemistry and Pathology, CHU de Québec, Université de Laval, Québec QC.
authors.forename: François
authors.initials: F
authors.lastname: Rousseau
authors.affiliation: Health Law Institute, Faculty of Law, University of Alberta, Edmonton AB.
authors.forename: Timothy
authors.initials: T
authors.lastname: Caulfield
mesh_terms: D005260:Female; D006801:Humans; D062145:Maternal Serum Screening Tests; D009774:Obstetrics / Q000331:legislation & jurisprudence / Q000639:trends*; D011247:Pregnancy; D018581:Technology Transfer; D057170:Translational Research, Biomedical
keywords: Commercialization; ethics; gynaecology; obstetrics; prenatal screening