Interview

Abstract

Roger D Klein, MD, JD, is the Medical Director of Molecular Oncology at BloodCenter of Wisconsin (WI, USA). He previously served as the Medical Director of Molecular Diagnostics at H Lee Moffitt Cancer Center (FL, USA), and Assistant Professor in the Department of Oncologic Sciences at University of South Florida Medical School (FL, USA). He earned his undergraduate and medical degrees and completed an internship in Internal Medicine at Case Western Reserve University (OH, USA). He completed residency training in Laboratory Medicine, together with fellowships in Medical Microbiology and Molecular Genetics at Yale University School of Medicine (CT, USA) followed by a fellowship in Molecular Genetic Pathology at Mayo Clinic (MN, USA). In addition, Dr Klein earned a law degree from Yale Law School, where he was named an Olin Fellow for Law and Public Policy Studies and served as an articles editor of the Yale Journal on Regulation. He is board-certified in Clinical Pathology and Molecular Genetic Pathology. Dr Klein is a member of the CDC’s Evaluation of Genomic Applications in Practice and Prevention Working Group (EGAPP), and is a consultant to the US FDA’s Clinical and Molecular Genetics Advisory Panel. He has served on the College of American Pathologists ‘Biochemical and Molecular Genetics’ and ‘Point-of-Care Testing’ Resource Committees, and is currently a member of the College of American Pathologists Molecular Oncology Resource Committee. He also serves on the Association for Molecular Pathology’s current procedural terminology (CPT) Coding and Professional Relations Committees. Dr Klein’s academic and clinical efforts focus on the translation of molecular genetic knowledge into clinical diagnostic tests for the evaluation and management of hematopoietic and solid tumor malignancies, and hereditary cancer syndromes. This work includes the assessment of the clinical validity, clinical utility and the optimal and appropriate use of molecular genetic tests. In addition, Dr Klein has an active research program involving the ethical, legal and social implications of the Human Genome Project, with particular emphases on the areas of intellectual property and the regulation of in vitro diagnostics and clinical laboratories. He has multiple publications in these areas.