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The conventional approach to medicine is rapidly changing to a data-driven strategy in which therapies are targeted to individual patients based on their unique genome, physiology, environment, and lifestyle. This approach is revolutionizing health care—especially in the treatment of cancer—but its success depends on the availability of reliable bioanalytical measurements, which can have many biases and uncertainties.  

For precision medicine to fulfill its promise, a measurement infrastructure is needed to assure the quality and reproducibility of diagnostic measurements. NIST contributes to this effort by working with stakeholders in the cancer community to 1) develop cancer biomarker reference materials to improve measurements in basic research and in the clinic, 2) evaluate data and assays to ensure confidence in discovery, and 3) conduct interlaboratory comparison studies to improve the accuracy and reliability of the measurements of new biomarkers. 



Immunohistochemical detection of HER2 cancer biomarker with IgY antibody and quantum dots is demonstrated in these samples of breast cancer cells from a patient with normal HER2 expression (left) and one with over production (right). Cell nuclei are stained blue, quantum dots responding to the HER2 protein light up in bright red at the cell membranes. Treatment with trastuzumab could only be effective for the latter patient.

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 contributes to this effort by 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 Cancer Biomarker Reference Materials 

NIST develops reference materials (RMs) 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. Our team is continually working with stakeholders to develop additional reference materials to improve measurement reliability and confidence for important cancer biomarkers. 

SRM 2373® — Genomic DNA Standards for HER2 Measurements 
Amplification of the gene for Human Epidermal Growth Factor Receptor 2 (HER2) occurs in approximately 20 to 25% of breast cancers. SRM 2373 consists of purified genomic DNA from five breast cancer cell lines with different amounts of HER2 gene. The SRM can be used to to assign ratios of HER2 gene to unamplified reference genes. This SRM is available from NIST as SRM 2373®.

RM 8366  — Gene Copy Number Standards for EGFR and MET Measurements   
Mutations or amplification of the genes for MET Proto-Oncogene (MET) and Epidermal Growth Factor Receptor (EGFR) can cause increased cellular signaling for cell growth or mobilization resulting in cancer. RM 8366 consists of of purified genomic DNA from six different cancer cell lines with different amounts of amplification of the EGFR and MET genes.  It is intended  to harmonize the measurements of ratios of the human EGFR and MET genes to unamplified reference genes.This RM is available from NIST as RM 8366

Biomarker Reference Laboratory 

NIST-EDRN Collaboration — NIST supports the National Cancer Institute (NCI) Early Detection Research Network (EDRN) as a Biomarker Reference Laboratory by working with the EDRN biomarker development and clinical testing labs to improve the rigor and reproducibility of measurements of cancer biomarkers for early cancer detection and risk assessment.


Created September 7, 2016, Updated January 2, 2020