Sr Director, Head of Regulatory, PGDx
Labcorp
Dr. Jennifer Dickey, PhD, RAC joined Personal Genome Diagnostics (PGDx) in January 2017 and served as the Vice President, Regulatory and Quality. PGDx was acquired by Labcorp in February 2022 and Dr. Dickey continues to serve as Head of Regulatory & Quality for PGDx, a Labcorp subsidiary. In her role at PGDx/Labcorp Dr Dickey lead the submission and authorization for the first liquid biopsy based tumor profiling kitted assay (PGDx elio plasma focus Dx) and the first kitted tumor profiling kitted IVD for FFPE tissue (PGDx elio tissue complete). Prior to her arrival at PGDx, Dr. Dickey served at the FDA for 7 years and mainly as Senior Scientific Reviewer in the Molecular Genetics branch of the Office of In Vitro Diagnostics and Radiological Health for 5 years. Dr. Dickey was Regulatory Affairs Certified (RAC) through the Regulatory Affairs Professional Society (RAPS) in 2012. She has played a leadership role in several regulatory initiatives including serving as Chair of the Next Generation Sequencing-based Oncology Panels Public Workshop (February 25, 2016) and as lead reviewer for the first NGS-based assay (Illumina assay for cystic fibrosis) to receive FDA authorization. Dr. Dickey has spoken at several association conferences on subjects such as Regulatory Review of NGS Assays; Potential Roles for NGS in Companion Diagnostics; FDA Review of NGS Technologies; Multi-Analyte NGS Assays; and Enabling NGS in Global Clinical Trials, additionally Dr. Dickey has co-authored numerous peer-reviewed articles. Jennifer received her PhD in Biochemistry from Vanderbilt University.
Thursday, October 9, 2025
9:15 AM - 10:30 AM EST