A cancer biomarker is a biological molecule found in blood, other body fluids, or tissues that is indicative of the presence of cancer. Biomarkers can be used for cancer risk assessment, diagnosis, prognosis of disease, and prediction of response to treatment. Many candidate markers for cancer diagnosis and treatment are identified, but very few prove useful when translated into the clinic. To focus valuable resources on the development of useful biomarkers, it is necessary to ensure that a rigorous system of quality assurance is in place in laboratories. NIST can play a critical role in helping labs to achieve a high degree of such quality assurance by providing reference materials, interlaboratory testing, and working with the labs to establish analytical validation of their measurement processes.
NIST develops reference materials for cancer biomarkers that can be used to improve measurements for the measurement assurance of assays used in basic research and for clinical measurements. The reference materials are developed in consultation with cancer experts from industry, academic, and government laboratories. We have developed a Standard Reference Material (SRM) for Human Epidermal Growth Factor Receptor 2 (HER2), a gene that is frequently amplified in breast cancer. The standard consists of purified genomic DNA from five breast cancer cell lines with different amounts of HER2 gene amplification. This reference material is available from NIST as SRM 2373.
We are also currently preparing a reference material for measurements of the genes for MET Proto-Oncogene (MET) and Epidermal Growth Factor Receptor (EGFR). Mutations or amplification of the genes for MET and EGFR can cause increased cellular signaling for cell growth or mobilization resulting in cancer. This new standard, when completed, will be available as Reference Material 8366. The standard consists of purified genomic DNA from six different cancer cell lines. Our team is continually working with stakeholders to develop additional reference materials to improve measurement reliability and confidence for important cancer biomarkers.
Biomarker Reference Laboratory
NIST supports the National Cancer Institute (NCI) Early Detection Research Network (EDRN) as a Biomarker Reference Laboratory by efficiently validating the measurement of potential biomarkers. By increasing the quality of the data produced at each of the stages in the biomarker discovery and validation processes, NIST and the EDRN are working to reduce both the time and resources expended in developing successful biomarkers. NIST analyzes the measurements of specific biomarkers, as identified by the EDRN discovery labs, and identifies critical areas where improvements will significantly impact the overall quality of the biomarker measurement.
Current EDRN/NIST Projects
2. Assay Evaluation of Mitochondrial DNA (mtDNA) Cancer Biomarkers in Urine
3. Measurement of MicroRNA