NIST develops cancer measurements by working with our stakeholders to deliver improved measurement methods, data, test materials, interlaboratory testing projects, and reference materials for cancer biomarkers that can be used to improve measurements of assays used in basic research and in clinical applications. The projects are developed in consultation with cancer experts from industry, academic, and government laboratories.
Collaborations and Cooperative Research Agreements
We welcome collaborations and can help with assay validation and development of reference materials. Below are some examples of our collaborations and ways we can develop test materials.
NIST Cancer Biomarker Reference Materials:
The amplification of the gene for Human Epidermal Growth Factor Receptor 2 (HER2) occurs in approximately 20 to 25% of breast cancers. The accurate measurement of this biomarker is important for the proper treatment with anti-HER2 therapeutics. Diagnostic tests like HER2 assays make it possible to select the best-personalized treatment for individual patients based on the genetic makeup of their tumors.
The copy numbers of the HER2 gene and 3 reference genes (not amplified) were measured using quantitative PCR and digital PCR assays. The certified values of the components are the ratios of the HER2 gene copy number to the reference gene copy numbers. The PCR assays were validated and calibrated using SRM®2372 component A (human genomic DNA). The stability of the components was shown by repeated measurements over several years. The DNA concentration determined from absorbance and the PCR assays was provided as informational value. This SRM is available from NIST as SRM 2373®.
We have developed genomic DNA RM for copy number measurements of the genes for MET and EGFR (Epidermal Growth Factor Receptor). MET and EGFR are both tyrosine kinase proteins found on the surfaces of cells that response to external growth factors. Mutations or amplification of the genes for MET and EGFR can cause increased cellular signaling for cell growth or mobilization resulting in cancer. The accurate measurements of these cancer biomarkers are important for the correct diagnostics to determine the treatment, since specific therapeutics are available for both of these targets.
RM 8366 consists of purified genomic DNA isolated from six different cancer cell lines with different amounts of amplification of the EGFR and MET genes (Fig.2). 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.