Cell-free Fetal DNA Testing for Fetal Aneuploidy and Beyond: Clinical integration challenges in the United States context.
PI: Mildred Cho, PhD
Contributors: Megan Allyse, PhD; Lauren Sayres, B.A.; Jaime King, J.D., PhD; Mary Norton, MD
Funders: This work was supported by NIH grant P50 HG003389 (Center for Integrating Ethics and Genetic Research)
Project Description: 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 in the future. However, it is not yet clear how these tests will be integrated into well-established prenatal testing strategies in the United States (US), as the timing of such testing and the degree to which new non-invasive tests will supplement or replace existing screening and diagnostic tools remains 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 US.