 | EPIGENETICS IN CANCER PREVENTION: EARLY DETECTION AND RISK ASSESSMENT
Copyright © 2003 by the New York Academy of Sciences
description
Annals of the New York Academy of Sciences 983:142-150 (2003)
© 2003 New York Academy of Sciences
Cancer Biomarker Validation: Standards and Process
Roles for the National Institute of Standards and Technology (NIST)
PETER E. BARKER
NIST-NCI Biomarkers Validation Laboratory, DNA Technologies Group, Biotechnology Division, NIST, Gaithersburg, Maryland 20899-8311, USA
Address for correspondence: Peter E. Barker, Ph.D., NIST-NCI Biomarkers Validation Laboratory, DNA Technologies Group, Biotechnology Division, NIST, Gaithersburg, MD 20899-8311. Voice: 301-975-5402; fax: 301-975-8505.
peter.barker{at}nist.gov
Ann. N.Y. Acad. Sci. 983: 142-150 (2003).
Rigorous validation of biomarkers for early detection of cancer differs at the National Institute of Standards and Technology (NIST) from similar processes common among research laboratories. As a newly discovered biomarker assay makes the transition from a research setting to the clinical diagnostic laboratory, it should progress through defined stages of assay confirmation. The first task of a validation laboratory is evaluation of research assay technology, performance, and specifications ( analytical validation). However, the ultimate goal is initial validation of the test to identify early stage cancer ( clinical validation). Upon technical and clinical confirmation, assays are moved systematically toward a standardized, reproducible, high-throughput format for clinical diagnostic implementation. With laboratory performance rigorously established, the clinical variables can subsequently be analyzed to define limitations, applications, and clinical utility. The role of NIST in technology evaluation for early cancer testing is described in the context of similar programs and prior experience at NIST. Here we conceptualize the validation steps of cancer test development and examine how NIST activities impact health care through institutional focus on measurement, technology, and standards development programs.
Key Words: cancer biomarker • assay validation • early detection • genetic technology • SRM • DNA • SELDI • standards • analytical validation
This article has been cited by other articles:
|
|
|
|
 
R. S. Vasan
Biomarkers of Cardiovascular Disease: Molecular Basis and Practical Considerations
Circulation,
May 16, 2006;
113(19):
2335 - 2362.
[Full Text]
[PDF]
|
|
|
|
|
|
|
Y. Li, D. Elashoff, M. Oh, U. Sinha, M. A.R. St John, X. Zhou, E. Abemayor, and D. T. Wong
Serum Circulating Human mRNA Profiling and Its Utility for Oral Cancer Detection
J. Clin. Oncol.,
April 10, 2006;
24(11):
1754 - 1760.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
P. A. Gimotty, P. Van Belle, D. E. Elder, T. Murry, K. T. Montone, X. Xu, S. Hotz, S. Raines, M. E. Ming, P. Wahl, et al.
Biologic and Prognostic Significance of Dermal Ki67 Expression, Mitoses, and Tumorigenicity in Thin Invasive Cutaneous Melanoma
J. Clin. Oncol.,
November 1, 2005;
23(31):
8048 - 8056.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. P. Jakupciak, P. E. Barker, W. Wang, S. Srivastava, and D. H. Atha
Preparation and Characterization of Candidate Reference Materials for Telomerase Assays
Clin. Chem.,
August 1, 2005;
51(8):
1443 - 1450.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. P. Jakupciak, W. Wang, M. E. Markowitz, D. Ally, M. Coble, S. Srivastava, A. Maitra, P. E. Barker, D. Sidransky, and C. D. O'Connell
Mitochondrial DNA as a Cancer Biomarker
J. Mol. Diagn.,
May 1, 2005;
7(2):
258 - 267.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. P. Jakupciak, W. Wang, P. E. Barker, S. Srivastava, and D. H. Atha
Analytical Validation of Telomerase Activity for Cancer Early Detection: TRAP/PCR-CE and hTERT mRNA Quantification Assay for High-Throughput Screening of Tumor Cells
J. Mol. Diagn.,
August 1, 2004;
6(3):
157 - 165.
[Abstract]
[Full Text]
|
|
|
|
|
|
|
E. Floyd and T. M. Mcshane
Development and Use of Biomarkers in Oncology Drug Development
Toxicol Pathol,
January 1, 2004;
32(1_suppl):
106 - 115.
[Abstract]
[PDF]
|
|
|
|
