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.