EDITOR-IN-CHIEF
editor ial
William S. Hancock Barnett Institute and Department of Chemistry Northeastern University 360 Huntington Avenue 341 Mugar Bldg. Boston, MA 02115 617-373-4881; Fax: 617-373-2855
[email protected] Do We Have Enough Biomarkers?
ASSOCIATE EDITORS
Joshua LaBaer Harvard Medical School
György Marko-Varga AstraZeneca and Lund University
EDITORIAL ADVISORY BOARD
Ruedi H. Aebersold Institute for Systems Biology
Leigh Anderson Plasma Proteome Institute
Ettore Appella National Cancer Institute
Rolf Apweiler European Bioinformatics Institute
Ronald Beavis Manitoba Centre for Proteomics
Walter Blackstock Cellzome
Brian Chait The Rockefeller University
Patrick L. Coleman 3M
Christine Colvis National Institutes of Health
Catherine Fenselau University of Maryland
Daniel Figeys MDS Proteomics
Sam Hanash University of Michigan
Stanley Hefta Bristol-Myers Squibb
Donald F. Hunt University of Virginia
Barry L. Karger Northeastern University
Daniel C. Liebler Vanderbilt University School of Medicine
Lance Liotta National Cancer Institute
Matthias Mann University of Southern Denmark
Stephen A. Martin Applied Biosystems
Jeremy Nicholson Imperial College of London
he Editor has become aware of a recent push to validate currently available biomarkers in an extensive clinical setting. The reasoning behind such a push is that there are already a significant number of biomarkers that now need to be used effectively in the clinic. Many biomarkers, such as the carcinoembryonic antigen, have been known for some time and are used widely for patient management. The older biomarkers, however, are not effective for early diagnosis. With the advent of genomics and, later, proteomics, there has been a substantial investment in using these new tools to generate additional biomarkers. The problem with this new information is that it is too early to get consensus on what is a useful marker or what is a good patient population for such a study. Therefore, it is unclear whether the new markers currently in hand will give better clinical information than the ones that have been used in the past. An additional problem is that the markers that are generated by proteomics are not always consistent with the markers that are generated from expression profiling. The challenge in this situation is to balance the need of patients for better, early diagnosis of disease with the need to have high-quality markers for the expensive and timeconsuming validation process. This Editor believes that proteomics is at too early a stage for this new technology to have generated a quality list of markers. The risk is if we push the existing markers into extensive clinical validation, we will be missing the fruits of improvements in emerging proteomics technology. I think many people in the proteomics community would agree that federal granting agencies should be enticed to continue investments in basic proteomics technology. In addition, funding should be made available for basic science studies that will continue to generate biomarkers, and there needs to be some type of consensus-building process that can lead to a consolidation of the different lists of biomarkers. There are good past models for such activities, such as the consensus-forming meetings that the U.S. Food and Drug Administration has held; these yielded technical innovations. One example was the generation of new protein pharmaceuticals at the advent of the biotechnology industry. Another example, in the early days of the genome sequencing program, was when a group of experts came together to agree on annotation of the early results. The Human Proteome Organization is a good example of an international group of laboratories coming together to consolidate the output from a number of studies with different technology platforms. I would like to encourage the biomedical community not to rush to judgment in terms of biomarkers, but instead to give research more time to produce quality biomarker information. Then we should conduct a thorough evaluation of a widely agreed-on list before we attempt to determine which of these new markers are indeed worthy of extensive clinical investigation.
T
Gilbert S. Omenn University of Michigan
Emanuel Petricoin Food and Drug Administration
J. Michael Ramsey Oak Ridge National Laboratory
Pier Giorgio Righetti University of Verona
John T. Stults Biospect
Peter Wagner Zyomyx
Keith Williams Proteome Systems
Qi-Chang Xia Shanghai Institute of Biochemistry
John R. Yates, III The Scripps Research Institute
© 2004 American Chemical Society
Journal of Proteome Research • Vol. 3, No. 4, 2004
685