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Health

Precision medicine

Projects/Programs

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Organizational Unit

NIST Genome Editing Consortium: Working Group 2 - Data & Metadata

Ongoing

Develop a metadata schema for genome editing experiments Develop a way of curating and entry that is low burden for user Release control data with linked metadata PROGRESS Phase1 metadata entries and templates completed In process of compiling and testing use cases, user interfaces, and

NIST Genome Editing Consortium

Ongoing

Targeted genome editing , a method used to alter the DNA of living cells at desired locations, is poised to revolutionize science and medicine. To fight diseases, novel genome edited therapeutics, including those for use in regenerative medicine and infectious diseases, are being developed. Many

NIST Genome Editing Consortium: Working Group 1 - Specificity Measurements

Ongoing

Genome editing technologies are able to produce DNA sequence changes of a variety of sizes and at a variety of frequencies in a population of edited cells. Having increased confidence in reliably detecting the sequences generated by a genome editing process was a need area identified. Project 1

NIST Genome Editing Lexicon

Ongoing

The definitions are worded with the intention that additional context may be added with supplementary language when they are used. It is also recognized that genome editing is a rapidly evolving biotechnology and additional terms and definitions will be needed as genome editing technologies mature

NIST Genome Editing Program

Ongoing

For genome editing systems to reach their full potential in research and commercial products, new measurement tools, capabilities, and standards must be developed to efficiently implement and assess the performance of these editing technologies, as well as to evaluate the utility of resulting

NIST HER2 Genomic DNA Standard Reference Material, SRM® 2373

Ongoing

The amplification of the gene for 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. Clinical laboratories are beginning to utilize accurate and sensitive diagnostic tests based on

NIST PS1 Primary Standard for quantitative NMR (Benzoic Acid)

Completed

With explicit SI linkage, the overall impact of this apical reference material is profound—this primary standard, as well as forthcoming members of its class, provides technology transfer of chemical purity realization to the commercial sector for characterization of many thousands of organic

NIST Urine Albumin Standardization Program

Ongoing

Kidney disease is a major global economic and public health issue, with chronic kidney disease (CKD) representing one of the top 10 most prominent causes of death worldwide. The public health and economic impact of CKD and other kidney diseases has led to the need for the accurate detection of

Pathogen Detection and Identification: The Next Generation of Analyses

Ongoing

Human disease resulting from pathogens represents a tremendous burden on the health care system. Many hospitals have adopted new, rapid polymerase chain reaction (PCR)-based detection systems because the time to diagnose and begin effective treatment has a direct impact on patient survival and

Performance Metrics for Proteomics

Ongoing

Intended Impact Proteomics experiments designed to identify protein markers specific to a particular disease or disease state rely on repeatable identification of proteins within a control set. Repeatability provides statistical assurance that clear differences between two sets (e.g. sick vs

Photonic Dosimetry

Ongoing

With this effort, NIST is responding to industry needs for traceable, measurement solutions that can resolve spatial variations of absorbed dose at the level of individual components on a silicon wafer or bacteria on surgical instruments. Presently, there is only limited traceability to national

Point-of-Care Pharmaceutical Manufacturing & Precision Medicine

Ongoing

We are employing quality by design (QbD) and risk assessment (cause-and-effect) approaches to investigate production technologies ( e.g., drop on demand or inkjet printing platforms) and appropriate analytical control strategies for point-of-care manufacture of narrow therapeutic index drugs

Quantitative Flow Cytometry Measurements

Ongoing

Flow cytometry is an essential tool for basic biotechnological and immunological research, the clinical discovery of potential therapeutics, development, and approval of drugs and devices, disease diagnosis, and therapeutic treatment and monitoring. For example, flow cytometry is commonly used in

Serology and Neutralization Assays for COVID-19

Ongoing

Multiplexed bead-based SARS-CoV-2 serological assay We have developed a validated multiplexed bead-based SARS-CoV-2 serological assay that measures different antibodies produced by a patient (IgG, IgM, IgA). In collaboration with the NIST Applied and Computational Mathematics Division, we have

Single-Cell Manipulation and Measurement

Ongoing

Mammalian cells are an important source material for applications in regenerative medicine, gene therapy, engineering biology, and genome editing. Traditional tools for manipulating mammalian cells operate at a bulk cell population level without precision manipulation of individual cells

Standards for Metagenomics

Ongoing

Metagenomics is a powerful technology combining high-throughput (a.k.a. “next-generation”) sequencing with advanced bioinformatics to identify and quantify mixtures of organisms in a sample. Metagenomics workflows consist of 4 main steps: Sample collection: location, amount, storage, etc. Extraction

U.S. TAG for ISO/TC276: Biotechnology

Ongoing

Get involved: Interested U.S. Stakeholders may participate in the US TAG at no cost. Membership provides access to all ISO/TC 276 and US TAG documents, including standards under development. Please click here to join. Contribute to standards development: Please click here to review, submit comment

Thermodynamic Principles Describe and Predict Cell Populations

Ongoing

Heterogeneity of cell populations indicates the many ways cells can process information. We study heterogeneity in gene expression by inserting a gene for a fluorescent protein downstream of the gene we are interested in, and we examine large numbers of cells by imaging or flow cytometry. We think

Trusted AI framework for a new class of Standard Reference Materials and Data with exquisitely characterized uncertainty for billions of properties

Ongoing

The measurement of diverse molecular classes in biospecimens containing millions of molecules, known as omics, is increasingly important in the life sciences and medicine, and used to find novel cancer therapeutics, discover COVID-19 infection pathways, and diagnose diseases. NIST RMs and SRDs for

Series of MRI images labeled A to E showing different views of brain tissue, some with gadolinium highlighted in blue against a purple background.

Understanding the Bioaccumulation of Gadolinium-Based Contrast Agents using Advanced Measurement Capabilities

Ongoing

Researchers and staff from the Medical University of South Carolina are collaborating with NIST staff experienced in trace elemental speciation, sample preparation and instrumental analysis in order to demonstrate the bioaccumulation of intact GBCA in patients who have repeated GBCA exposure

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