Dr. Pratt is a Medical and Clinical Molecular Geneticist board-certified by the American College of Medical Genetics. Prior to joining Indiana University, she was Chief Director, Molecular Genetics, for Quest Diagnostics Nichols Institute. Dr. Pratt is the Past President of Association for Molecular Pathology. Dr. Pratt is also the Past Chair of the Genetics, Clinical Practice and the Program committees and is currently a member of the Economic Affairs committee for AMP. Dr. Pratt serves on the AMA Molecular Pathology Current Procedural Terminology (CPT) Advisory committee. Dr. Pratt continues to serve on the CDC GeT-RM program for reference materials. She is currently serving on the National Academy of Medicine’s Roundtable on Genomics and Precision Health. Previously, Dr. Pratt served on the CMS Clinical Diagnostic Laboratory Tests Advisory Panel and was an advisor of EurogenTest for genetic test validation.
Aided by new practice guidelines and recommendations by the Clinical Pharmacogenetics Implementation Consortium (CPIC), the field of pharmacogenomics (PGx) has grown both in those offering testing services and in providers utilizing this technology. At the same time, the FDA is actively creating policy and standards for PGx services by setting special controls associated with over-the-counter PGx testing, issuing a safety alert, and sending warning letters and other communications to laboratories. This session will review recent FDA activity and explore its significance for more substantial changes to diagnostic regulatory policy and implications for patients, providers, and diagnostic developers.