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PROJECTS/PROGRAMS

NIST Genome Editing Program

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.

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 — 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:

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:

Physical Measurements
Data & Metadata
Documentary Norms & Standards

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

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

Created May 11, 2022, Updated May 12, 2023