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 for early detection of cancer and for cancer risk. 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 collaborating to reduce both the time and resources expended in developing successful biomarkers.
Our lab is one of the EDRN Biomarker Reference Laboratories working with the EDRN discovery labs to improve the quality of the measurements done on new cancer biomarkers for early detection of cancer and for cancer risk.
The test materials that NIST develops are made by studying the characteristics of biomarkers that are detected in patient samples. A better understanding of biomarkers found in patient samples allows NIST to improve measurement methods and develop materials that will simulate patient samples. If test materials prove to be useful for discovery labs, NIST further develops them into formal reference materials. Working with the discovery labs to better understand biomarker assays and determining the important characteristics of test samples through interlaboratory testing allows NIST to produce optimal reference materials.
1. Development of Reference Materials for Circulating Cell Free Tumor DNA for Cancer Diagnostics — Tumor shed DNA into the body and the DNA mutations can be used for cancer detection treatment monitoring. Circulating cell free tumor DNA can be found at low concentrations and is degraded in patient blood with a size of approximately 140 base pairs. We are developing measurement methods and in-house NIST reference materials based on spiking in synthetic DNA allele variants into a background of wild type DNA. NIST has found that the physical properties of the DNA used to prepare the test materials is critically important to achieve results that are compatible with patient samples and are working on methods to prepare the DNA samples
2. DNA Methylation Reference Material Development — We are working with the early cancer discovery labs to identify new DNA methylation biomarkers, to improve measurement methods, and develop reference samples to improve the quality of measurements of methylated DNA biomarkers for early detection of cancer. We are currently working with biomarker discovery labs to determine best ways we can help them to validate their biomarkers.
3. Development of methods, data, and reference samples for liquid biopsy methods for measurements of cancer biomarkers present in extracellular vesicles (EVs). Tumors can release large amounts of membrane bound sub-cellular vesicles that contain specific biomarkers for cancer. NIST works with laboratories by evaluating different EV detection methods for across method comparability and determining needs for improved measurement methods, data, and reference samples for enabling early cancer detection.