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 — Circulating cell free tumor DNA can be found at low concentrations and degraded in patient’s blood, at a size of approximately 140 base pairs. An interlaboratory testing program is underway to test the effectiveness of a commercial ctDNA control materials with 40 mutant alleles. NIST is also developing 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 — NIST is working on the development of reference materials suitable for assuring 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. Gene Copy Number Variations (CNV) Reference Materials for Liquid Biopsy — NIST is working on the development of reference materials suitable for assuring the quality of measurements of gene copy number biomarkers for early detection of cancer. We are working with biomarker discovery labs to determine the best ways we can help them to validate their biomarkers.
4. Measurement of MicroRNA — To improve the confidence in the measurement of microRNAs as potential cancer biomarkers, NIST is developing reference samples and coordinating interlaboratory testing using microRNAs (miRNA).
Article: E. V. Stein, D. L. Duewer, N. Farkas, L. Wang, K. D. Cole. November 16, 2017. Steps to achieve quantitative measurements of microRNA using two step droplet digital PCR.
5. Assay Evaluation of Mitochondrial DNA (mtDNA) Cancer Biomarkers in Urine — NIST is evaluating assays for mtDNA measurement from urine samples as well as confirming mtDNA as a potential prostate cancer biomarker.
Article: S. D. Maragh, S. P. Lund. August 17, 2015. Evaluation of two mitochondrial DNA biomarkers for prostate cancer detection. Cancer Biomarkers.