Delivering high quality genomics-informed care to patients requires accurate test results whose clinical implications are understood. While other actors, including state agencies, professional organizations, and clinicians, are involved, this article focuses on the extent to which the federal agencies that play the most prominent roles — the Centers for Medicare and Medicaid Services enforcing CLIA and the FDA — effectively ensure that these elements are met and concludes by suggesting possible ways to improve their oversight of genomic testing.
Bibliographical noteFunding Information:
Preparation of this article was supported by National Institutes of Health (NIH) grants R01 HG008605 as part of the project on “LawSeq: Building a Sound Legal Foundation for Translating Genomics into Clinical Application” and RM1 HG009034. The content is solely the responsibility of the authors and does not necessarily represent the views of the funders. We particularly thank our colleagues Kenny Beckman and Susan Berry for their helpful comments in discussion. Research assistance was provided by Emily Sachs, Hailey Verano, Jillian Heaviside, Margo Wilkinson, Ahsin Azim, and Kate Hanson. Coordination of the group's work was provided by the incomparable Audrey Boyle. All views expressed are those of the authors and not necessarily the funders or others who provided support and comments.
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