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PROJECTS/PROGRAMS

NIST Genome Editing Program

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Summary

Genome Editing technologies have transformed the potential of biosciences and biotechnology by providing precision engineering tools that enable modifications to be made at specified positions within the genetic code of living cells. This rapidly evolving technology area is being adopted to advance many sectors of the bioeconomy including: human health (eg., cell and gene therapies, microbial-based diagnostics and therapeutics), agriculture, engineering/synthetic biology, environment, and biomanufacturing. 

The NIST Genome Editing Program develops standards, methods, tools, technology, and community norms to advance the reliability of genome editing technology and foster confidence in measurements for the genome editing field.

Infographic depicting the vision and goal for the NIST Genome Editing Program. On top is a circle with a light bulb icon representing the vision. Extending from the circle is a dark blue text box with white text describing the vision. Similarly, on the bottom is a circle with a target icon indicated for the goal and a dark blue text box with white text defining the goal of the program.
Credit: BioRender.com
NIST-print-2.0
NIST-print-2.0
Created by Simona Patange on the NIST FluidFM OMNIUM system that is under evaluation for single cell genome editing applications.

Description

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 products (e.g., engineered cells) for their intended purposes.

The NIST Genome Editing Program actively supports this growing industry by:

Three icons separated by vertical thin lines: a clipboard with checkmarks and a pencil beside it (representing evaluating), a check mark within a circle (representing qualifying), and three gears within a circle made up of two arrows (representing developing)
Credit: BioRender.com

NIST GENOME EDITING PROGRAM FOCUS AREAS

The NIST Genome Editing Program is focused on three primary areas: 1) Physical Measurements, 2) Data & Metadata, and 3) Documentary Norms and Standards. 

A triangle representing the 3 primary focus areas of the NIST Genome Editing Program. There are lines emanating from the three lines of the triangle to separate the focus areas and describe them with text boxes.
Credit: Created in https://BioRender.com

NIST GENOME EDITING CONSORTIUM

The NIST Genome Editing Consortium is a public-private partnership with genome editing stakeholders to define measurement challenges for utilizing existing measurement capabilities to understand genome editing outcomes and develop shared solutions.

 

QUALIFICATION OF ASSAYS FOR DETECTING GENOME WIDE OFF-TARGET ACTIVITY OF GENOME EDITING MOLECULES

NIST is working closely with technology developers and other federal agencies to apply measurement assurance (including bioinformatics), associated tools, and well-documented protocols to improve reliability and reproducibility of recently developed assays for detecting off-target activity of genome editing molecules.

Current Project Collaborators and Assays:

CHANGE-Seq

  • NIH Somatic Cell Genome Editing (SCGE) Common Fund Program
  • St. Jude Children’s Research Hospital, Lab of Shengdar Tsai, PhD

ONE-Seq

  • DARPA SafeGenes Program
  • Massachusetts General Hospital, Lab of J. Keith Joung, MD/PhD
  • SeQure Dx

INDUCE-seq

  • Health and Environmental Sciences Institute (HESI)
  • Novartis
  • AstraZeneca
  • BrokenStrings Biosciences
 

ASSESSMENT OF GENOME EDITING REAGENTS & TECHNOLOGIES

Genome editing molecules to be introduced into a cell and/or organism can be formulated in various formats including: DNA, short RNA (in vitro transcribed and synthetic with or without modifications), mRNA, and protein. Additionally, there are several options for technologies to physically deliver genome editing molecules into cells and/or organisms. The NIST Genome Editing Program is actively assessing strategies for evaluating the properties, capabilities, and limitations of different genome editing molecule formulations as well as approaches for delivering genome editing molecules into cells.

Genome editing molecule delivery platforms under evaluation:
  • FluidFM OMNIUM (Cytosurge AG)
  • Neon (ThermoFisher)
  • Nucleofector 4D (Lonza)

Any mention of commercial products within NIST web pages is for information only; it does not imply recommendation or endorsement by NIST.

PUBLICATIONS

RELATED NEWS

Bioscience, Bioinformatics, Biomanufacturing, Engineering / synthetic biology, Genome editing, Genomics, Health, Precision medicine and Regenerative medicine and advanced therapy
Created May 11, 2022, Updated December 31, 2024