Given the rapid advances in genomics, translating new genomic tests effectively into prenatal clinical practice remains challenging. We discuss emerging genetic tests, considerations for their use, how tests should ideally be validated prior to use in clinical practice, and the role of the Federal Drug Administration, Clinical Laboratory Improvement Amendments (CLIA) laboratories, commercial laboratories, insurers, and professional societies such as the American College of Obstetricians and Gynecologists (ACOG), and the Society for Maternal-Fetal Medicine (SMFM) in the introduction of new prenatal genetic tests. After the introduction of new tests into the prenatal clinic, it is critical to utilize shared databases with measured outcomes to improve clinical care as well as to advance science.
Keywords: genetics; implementation; prenatal; sequencing.
Copyright © 2018. Published by Elsevier Inc.