We collaborate with key stakeholders to develop and disseminate NIST products that enable comparison, ensure interoperability, and support commerce for emerging biotechnologies and engineering biology. We also lead and contribute to various Standards Developing Organizations (SDOs) including ISO/TC 276 and ASTM F04.
Our laboratory programs provide the necessary expertise, fundamental measurement science, data, and advanced technologies to underpin development of standards, including documentary standards, reference materials (RMs), reference data, and software tools.
Examples of standards leadership and development activities include:
- ISO/TC 276: Biotechnology: NIST chairs and administers the U.S. Mirror Committee to ISO/TC 276: Biotechnology, which develops standards for all sectors of biotechnology. NIST has created an inclusive, collaborative environment among 100+ organizations to best represent U.S. interests while promoting international cooperation.
- Advanced Therapies - Under the previsions enacted under the 21st Century Cures Act (Public Law 114–255), NIST continues to work with the U.S. FDA, the Standards Coordinating Body, and other stakeholders to coordinate the development of standards for regenerative medicine therapies. Work is underway to develop processes and criteria for identifying, prioritizing, and assessing the quality, safety, feasibility, and cost-benefit of such standards.
- NIST Genome Editing Consortium: The Consortium recently released a unified standard set of terms and definitions serving the needs of the genome editing community. These definitions will provide critical support to various scientific and policy discussions.
- Cancer Biomarker RMs: Genomic DNA RMs for cancer biomarkers were developed to improve measurements of assays used in basic research and clinical applications.
- Genome in a Bottle Human Genome RMs: Seven authoritatively characterized human genomes are available to benchmark sequencing and bioinformatic analysis pipelines.
- Yeast RM: A living microbial RM consisting of freeze-dried Saccharomyces cerevisiae NE095 yeast cells is characterized for total cell count to compare and challenge cell enumeration and DNA-based detection technologies.