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Summary

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.

Genome editing technologies (e.g., CRISPR/Cas systems, meganucleases, TALENS, zinc-finger proteins) 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 (e.g., cell and gene therapies, microbial-based diagnostics and therapeutics), agriculture, engineering/synthetic biology, environment, and biomanufacturing.

Vision: Foster technological innovation and enable quality in measurements to accelerate the translation and commercialization of  genome edited products

Goal: Develop measurement tools and standards to increase the confidence of utilizing genome editing technologies in research and commercial products

NIST-print-2.0
NIST-print-2.0
Created by Simona Patange on the FluidFM OMNIUM system, one of several technologies that are under evaluation for single-cell genome editing applications. Any mention of commercial products by NIST is for information only; it does not imply recommendation or endorsement by NIST.

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:

  • Evaluating measurement challenges related to implementing genome editing systems and understanding genome editing outcomes
  • Qualifying analytical methods being used to detect and assess genome editing outcomes
  • Developing new methods and standards to support confidence in detecting, interpreting, and reporting about genome editing outcomes

The NIST Genome Editing Program focus areas:

  1. Physical measurements
  2. Data and metadata
  3. Documentary norms and standards
NIST Genome Editing Program focus areas
Created with 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.

Project collaborators and assays currently under evaluation:

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

Tools for ASSESSing GENOME EDITING REAGENTS & TECHNOLOGIES

We are developing measurements and assays that allow users to understand how a particular set of reagents or a technology is working in their own labs. 

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 and/or single cell analysis platforms under evaluation:

  • FluidFM OMNIUM (Cytosurge AG)
  • Neon (ThermoFisher)
  • Nucleofector 4D (Lonza)
  • Tapestri (Mission Bio)

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

PUBLICATIONS

Created May 11, 2022, Updated May 25, 2022