Tumor Markers Quality Requirements

The National Academy of Clinical Biochemistry

Laboratory Medicine Practice Guidelines

Use of Tumor Markers in Clinical Practice: Quality Requirements

Publication Date: 2008

These guidelines are intended to encourage more appropriate use of tumor marker tests by primary care physicians, hospital physicians and surgeons, specialist oncologists, and other health care professionals. The background and methodology described within this document represent the larger undertaking to address tumor markers in clinical practice of which this set of guidelines is a part. The recommendations contained herein are based upon the best available evidence and consensus of expert contributors and reviewers. Toward this effort, draft revisions of these guidelines were prepared and placed for comment on the NACB web site. The guideline chapters resulting from this process have been published in appropriate peer-reviewed laboratory medicine and specialty clinical journals to assist with dissemination among the target groups.

Guidelines Committee:

  • Catherine Sturgeon, PhD, Department of Clinical Biochemistry, Royal Infirmary of Edinburgh, Edinburgh, United Kingdom
  • Eleftherios P. Diamandis, PhD, Department of Pathology and Laboratory Medicine, Mount Sinai Hospital, and Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada
  • Barry R. Hoffman, PhD, Department of Pathology and Laboratory Medicine, Mount Sinai Hospital, and Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada
  • Daniel W. Chan, PhD, Department of Pathology, Center for Biomarker Discovery, Johns Hopkins Medical Institutions, Baltimore, MD, USA
  • Soo-Ling Ch’ng, PhD, MD, Tanjung Bungah, Penang, Malaysia
  • Elizabeth Hammond, PhD, Department of Pathology, LDS Hospital, Salt Lake City, UT, USA
  • Daniel F. Hayes, MD, Breast Oncology Program, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI, USA
  • Lance A. Liotta, PhD, Center for Applied Proteomics and Molecular Medicine, College of Sciences, George Mason University, Manassas, VA, USA
  • Emmanuel F. Petricoin, PhD, Center for Applied Proteomics and Molecular Medicine, College of Sciences, George Mason University, Manassas, VA, USA
  • Manfred Schmitt, PhD, Clinical Research Unit, Department of Obstetrics and Gynecology, Technical University of Munich, Munich, Germany
  • O. John Semmes, PhD, Department of Microbiology and Molecular Cell Biology, Center for Biomedical Proteomics, Eastern Virginia Medical School, Norfolk, VA, USA
  • Györg Söletormos, PhD, Department of Clinical Biochemistry, Hillerød Hospital, Hillerød, Denmark
  • Elena van der Merwe, PhD, Department of Pathology and Laboratory Medicine, Mount Sinai Hospital, and Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada
This LMPG was developed by an independent committee of the NACB. Subsequent publication of these guidelines has been supported by the Academy.