Cancer Biomarker Validation: Standards and Process - Roles for the National Institute of Standards and Technology (NIST)

Published

January 1, 2003

Author(s)

Peter E. Barker

Abstract

Rigorous validation of biomarkers at the National Institute of Standards and Technology (NIST) for early detection of cancer differs 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 healthcare through institutional focus on measurement, technology and standards development programs.

Proceedings Title

Epigenetics in Cancer Prevention: Early Detection and Risk Assessment

Volume

983

Conference Dates

December 3-4, 2001

Conference Location

Bethesda, MD

Conference Title

Conference on Epigenetics in Cancer Prevention

Pub Type

Conferences

Keywords

analytical validation, assay validation, cancer biomarker, DNA, early detection, genetic technology, standards, WELDI SRM

Citation

Barker, P. (2003), Cancer Biomarker Validation: Standards and Process - Roles for the National Institute of Standards and Technology (NIST), Epigenetics in Cancer Prevention: Early Detection and Risk Assessment, Bethesda, MD (Accessed December 14, 2024)