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Precision Medicine
SUMMARY
Complex diseases can arise from numerous genetic, lifestyle, and environmental factors. Precision medicine aims to develop patient specific disease prevention and treatment strategies that target the molecular basis of disease. Robust measurements for identification and analysis of biomarkers are essential for reliable prediction of patient outcomes and the development of targeted therapies against disease causing molecules. Biomarkers that change in response to disease can also be used to detect and monitor disease progression. NIST works with partners and stakeholders to provide the measurement infrastructure essential for achieving the promise of precision medicine. We consult with the healthcare community to prioritize our work on the most relevant measurement issues to ensure the efficacy and safety of products. NIST provides measurement methods, reference materials, and interlaboratory testing to support these goals.
Programs and Projects to Support Precision Medicine
Genome Editing Program and Consortium: This program is designed to bring together experts across the genome editing field to 1) Investigate specificity and measurements of off-target edits; 2) stablish genome editing data and metadata standards; and 3) Establish a unified lexicon for describing genome editing processes.
Human Genome Measurements, Bioinformatics, and the Genome in a Bottle Consortium: This program authoritatively characterizes NIST human genome reference materials to benchmark human genome sequencing and bioinformatics methods. An open consortium brings together the technology development, research, and clinical communities to translate new technologies and methods to precision medicine in the clinic and improve the quality of genomic measurements.
Cancer Biomarker Measurements and Collaborations: This program provides the research and clinical communities cancer biomarker measurement methods, data, and reference materials to ensure confidence and reliability. The principal focus areas of this program include biomarkers in liquid biopsies (blood, urine, saliva, and other biofluids), such as circulating cell free tumor DNA, methylated DNA biomarkers, and extracellular vesicles.
Human Microbiome Program and External Partnerships: The NIST microbiome program is working to develop measurement assurance tools that support the clinical translation of microbiome science. Ongoing activities include the development of a human gut microbiome (human fecal) reference material and a suite of multi-omic measurement tools. NIST also co-founded and co-leads the International Microbiome and Multi-’Omics Standards Alliance (IMMSA) which hosts quarterly webinars and biennial workshops.
Measurements and Standards for Cancer Immunotherapy: The initial project in this area is a collaboration with stakeholders to provide reference materials for Lentiviral vector copy number (VCN) measurements. By transducing human T cells with a lentivirus expressing an anti-CD19 cassette, NIST is working on the development of standard clonal anti-CD19 CAR T model cell lines and single cell VCN measurements for CAR T-cell therapy.
Quantitative Flow Cytometry: This project develops measurement methods, reference materials, and measurement services for aiding measurement confidence in flow cytometric assays characterizing human immune cells and extracellular vesicles in precision medicine applications.
Cell Line Authentication: This project establishes measurement methods and data to confirm the identity of mouse and other cell lines used in research and production of biologicals.
Next Generation Metrics for Cell Therapies and Regenerative Medicine: Using high speed imaging of living cells and AI models for analysis, NIST is collecting unparalleled data of the dynamic cellular characteristics that give rise to complex biological functions.
Standards for Immunohistochemistry (IHC): A collaboration with Tufts University and Boston Cell Standards to provide a quantitative approach for IHC measurements, including the antibodies used for checkpoint inhibitors (anti-PD-L1) therapies for cancer.
Development of Broadly Consented Matched Tumor/Normal Cell Lines for Reference Materials: A collaboration with cancer research centers to establish broadly consented matched normal and tumor-derived cell culture lines suitable for developing genomic NIST reference materials and commercial development. NIST is currently working with the Genome in a Bottle Consortium to extensively sequence the first tumor/normal pair and develop benchmarks for somatic variants.
Standards Development
NIST develops standards for precision medicine that can be used for the measurement assurance of assays used in basic research and in clinical laboratories.
- Nucleic Acid Reference Materials (RMs)
- Global Alliance for Genomics and Health Benchmarking Team
- Human Gut Microbiome (a.k.a. Human fecal) Reference Materials
Stakeholder Engagement
NIST standards are developed in consultation with experts from industry, academic, and government laboratories.
- NCI Early Detection Research Network
- Genome Editing Consortium
- Genome in a Bottle Consortium
- Flow Cytometry Standards Consortium
- International Microbiome and Multi-’Omics Standards Alliance (IMMSA)
Contacts
Leader, Biomarker and Genomic Sciences Group
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(301) 975-4133
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(301) 975-4947