title: Cell-free fetal DNA testing for fetal aneuploidy and beyond: clinical integration challenges in the US context.
abstract: The recent release of new, non-invasive prenatal tests for fetal aneuploidy using cell-free fetal DNA (cffDNA) has been hailed as a revolution in prenatal testing and has triggered significant commercial interest in the field. Ongoing research portends the arrival of a wide range of cffDNA tests. However, it is not yet clear how these tests will be integrated into well-established prenatal testing strategies in the USA, as the timing of such testing and the degree to which new non-invasive tests will supplement or replace existing screening and diagnostic tools remain uncertain. We argue that there is an urgent need for policy-makers, regulators and professional societies to provide guidance on the most efficient and ethical manner for such tests to be introduced into clinical practice in the USA.
authors.affiliation: Stanford Center for Biomedical Ethics, Stanford, CA 94305-5417, USA. megand@stanford.edu
authors.forename: Megan
authors.initials: M
authors.lastname: Allyse
authors.forename: Lauren C
authors.initials: LC
authors.lastname: Sayres
authors.forename: Jaime S
authors.initials: JS
authors.lastname: King
authors.forename: Mary E
authors.initials: ME
authors.lastname: Norton
authors.forename: Mildred K
authors.initials: MK
authors.lastname: Cho
mesh_terms: D000782:Aneuploidy; D002474:Cell-Free System; D002869:Chromosome Aberrations / Q000196:embryology*; D004247:DNA / Q000235:genetics* / Q000302:isolation & purification; D003663:Decision Trees; D005260:Female; D005820:Genetic Testing / Q000639:trends; D006801:Humans; D017410:Practice Guidelines as Topic; D011247:Pregnancy; D011296:Prenatal Diagnosis / Q000009:adverse effects / Q000379:methods*; D014481:United States
chemical_list: D004247:DNA