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Bioscience

Projects/Programs

Keyword

Organizational Unit

What is an allelic ladder? An allelic ladder is a mixture of highly characterized alleles (known size and sequence) that are generated using the same primers as the test samples and are used during capillary electrophoresis for accurate allele call determination. Why is an allelic ladder important

Mpox (MPXV) Synthetic DNA PCR Standards

Ongoing

A new material from NIST can aid in the evaluation and development of selected qPCR assays for the mpox virus. We are offering a unit free of charge in exchange for your feedback, which will help us improve and further develop the material. Questions? Contact MPXV-RGTM [at] nist.gov (MPXV-RGTM[at]nist[dot]gov) . NIST supports the

NIST/EDRN Cancer Biomarker Collaboration

Completed

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. TECHNICAL APPROACH Evaluate current assays used for detection of cancer

NIST/FDA CVM Evaluation of Assays and Control Materials for Characterizing Genome-Edited Animal Biotechnology Products

Ongoing

FDA CVM oversees regulation of IGAs in animals, including those that have been created using genome editing technologies. Characterization of these IGAs is an important part of the regulatory process to ensure that the edit to the animal’s genome is what it is intended to be and to identify any

NIST Flow Cytometry Standards Consortium 

Ongoing

Advances in cell and gene-based therapeutics as well as other regenerative medicine products have increased the need for high quality, robust, and validated measurements for cell characterization. Flow cytometry, including imaging cytometry, has emerged as an important platform due to its ability to

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 Microbial Strain Collection

Ongoing

Microorganisms of interest include but are not limited to those relevant to: biomanufacturing of advanced therapy products; rapid microbial testing; microbial therapeutics (e.g., live biotherapeutic products, probiotics, and fecal microbiota transplantations (FMTs)); infectious disease

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

RMAT Laboratory Programs

Ongoing

Examples of Current Activities: Cell Counting and viability are key measurements critical for decision making from R&D to manufacturing. We recently developed an approach for evaluating the quality of cell counting measurements through experimental design and statistical analysis that does not

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

Synthetic Biology Standards Consortium (SBSC)

Completed

The SBSC is an open and voluntary consortium consisting of private companies, academic researchers, and public entities convened and hosted by NIST. The objective of the SBSC is to collectively build the metrology infrastructure to support a fully integrated, global synthetic biology enterprise. A

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

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

Wastewater Surveillance

Ongoing

NIST is partnering with the Department of Homeland Security Science and Technology Directorate (DHS/S&T) to develop documentary standards and reference materials to support an enduring capability in wastewater surveillance. Ongoing activities include: Development of a research grade test material

Genomics

Projects/Programs

Mouse Allelic Ladder

Mpox (MPXV) Synthetic DNA PCR Standards

NIST/EDRN Cancer Biomarker Collaboration

NIST/FDA CVM Evaluation of Assays and Control Materials for Characterizing Genome-Edited Animal Biotechnology Products

NIST Flow Cytometry Standards Consortium

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

NIST Genome Editing Consortium

NIST Genome Editing Consortium: Working Group 1 - Specificity Measurements

NIST Genome Editing Lexicon

NIST Genome Editing Program

NIST HER2 Genomic DNA Standard Reference Material, SRM® 2373

NIST Microbial Strain Collection

Pathogen Detection and Identification: The Next Generation of Analyses

RMAT Laboratory Programs

Serology and Neutralization Assays for COVID-19

Single-Cell Manipulation and Measurement

Standards for Metagenomics

Synthetic Biology Standards Consortium (SBSC)

U.S. TAG for ISO/TC276: Biotechnology

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

Wastewater Surveillance

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