title: Current State of PCR-Based Epstein-Barr Virus DNA Testing for Nasopharyngeal Cancer.
abstract: Clinical studies have shown plasma Epstein-Barr virus (EBV) DNA level to be an independent prognostic biomarker for nasopharyngeal carcinoma (NPC). However, the proportion of NPC patients whose tumors are associated with EBV vary with geographic location, and there are a variety of assays for plasma EBV. To develop the level of evidence needed to demonstrate the clinical utility of plasma EBV DNA detection for NPC patients and encourage widespread adoption of this biomarker test in clinical laboratories, validated harmonized assays are needed. In 2015, the National Cancer Institute (NCI) convened a Workshop on Harmonization of EBV Testing for Nasopharyngeal Cancer, where experts in head and neck oncology and laboratory medicine addressed the limitations of currently available polymerase chain reaction-based EBV DNA quantitation assays and discussed strategies for advancing the development of harmonized EBV DNA assays and their appropriate clinical use. This article presents the key recommendations to direct future efforts in assay harmonization and validation.
authors.affiliation: Cancer Diagnosis Program, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
authors.forename: Kelly Y
authors.initials: KY
authors.lastname: Kim
authors.affiliation: Department of Radiation Oncology, Stanford University School of Medicine, Stanford, CA, USA.
authors.forename: Quynh-Thu
authors.initials: QT
authors.lastname: Le
authors.affiliation: Department of Radiation Oncology, University of California, San Francisco, CA, USA.
authors.forename: Sue S
authors.initials: SS
authors.lastname: Yom
authors.affiliation: Departments of Pathology and Medicine, Stanford University School of Medicine, Stanford, CA, USA.
authors.forename: Benjamin A
authors.initials: BA
authors.lastname: Pinsky
authors.affiliation: Department of Radiation Oncology, Princess Margaret Cancer Centre/University of Toronto, Toronto, Ontario, Canada.
authors.forename: Scott V
authors.initials: SV
authors.lastname: Bratman
authors.affiliation: Department of Otolaryngology, Head and Neck Surgery, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Raymond H W
authors.initials: RH
authors.lastname: Ng
authors.affiliation: Division of Microbiology Devices, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Haja S
authors.initials: HS
authors.lastname: El Mubarak
authors.affiliation: Department of Chemical Pathology, State Key Laboratory in Oncology of South China, The Chinese University of Hong Kong, Hong Kong SAR, China.
authors.forename: K C Allen
authors.initials: KC
authors.lastname: Chan
authors.affiliation: Page One Editorial Services, Boulder, CO, USA.
authors.forename: Miriam
authors.initials: M
authors.lastname: Sander
authors.affiliation: Cancer Diagnosis Program, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
authors.forename: Barbara A
authors.initials: BA
authors.lastname: Conley
mesh_terms: D014408:Biomarkers, Tumor / Q000097:blood; D003226:Congresses as Topic; D004279:DNA, Viral / Q000097:blood*; D004854:Herpesvirus 4, Human / Q000235:genetics*; D006801:Humans; D009303:Nasopharyngeal Neoplasms / Q000097:blood* / Q000628:therapy / Q000821:virology*; D016133:Polymerase Chain Reaction / Q000592:standards*; D015203:Reproducibility of Results
chemical_list: D014408:Biomarkers, Tumor; D004279:DNA, Viral