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Biomarker and Genomic Sciences Group

The Biomarker and Genomic Sciences Group develops and applies standards and methods for all analytical and bioanalytical measurements pertinent to instrument calibration and validation to ensure bioassay performance for identification and quantitation of molecular and biological species.

The Biomarker and Genomic Sciences Group develops standards and methods for improving confidence in fundamental measurements in biology through new and improved techniques, methodologies, and standards based on optical and genomic methods. We are focused on improving the quantitative measurements of biological markers of gene expression in eukaryotic cells and biological fluids. We are providing tools that can be used for bioanalytical measurements pertinent to instrument calibration and analytical validation. We work with the stakeholders in the research and clinical analysis communities to determine their needs and opportunities where we can strategically focus our efforts. We identify the existing and future standards needs ranging from device calibration and instrument performance to the development of biological reference materials and procedures. The group has active projects in the development of genomic standards to support cancer diagnostics and therapeutics, in reference materials for quantitative flow cytometry, in the development of genomic markers for cell line authentication, and in measurements for assessing the results of genome editing. 



    Precision Medicine for Cancer Diagnostics—The conventional approach to medicine is rapidly changing to a data-driven strategy in which therapies are individually targeted to a patient based on genome, physiology, environment, or lifestyle...

    Measurement of Low Frequency Mutations in Circulating Tumor DNA (ctDNA) through Interlaboratory Testing—A very exciting development in the diagnosis and therapeutic monitoring of cancer is the discovery that blood and urine contain nucleic acids derived from cancer cells that can be used to as biomarkers...

    Quantitative Flow Cytometry—We work in collaboration with other government agencies, private industry, academia, professional societies, and other national metrology institutes to ensure that flow cytometry measurements are …

    Thermodynamics of Enzyme-catalyzed Reactions—To develop the thermodynamic data and methodology required for effective bioprocess engineering...

    Quantification of Cells with Specific Phenotypic Characteristics—Flow cytometers are versatile instruments that have been successfully used to enumerate cell subsets in infectious diseases (e.g., HIV) and to diagnose malignancies through changes in the …