NTI-WEF Technical Consortium for DNA Synthesis Screening Comments on Revised U.S. Government Guidance

The Technical Consortium for DNA Synthesis Screening, convened by NTI | bio and the World Economic Forum (WEF), responded this week to the U.S. government’s request for comment on its Revised Screening Framework Guidance for Providers and Users of Synthetic Oligonucleotides—fragments of DNA or RNA. The government’s Revised Guidance was published in April 2022 as an update to the influential guidance initially established in 2010 that set standards for screening customers and DNA sequences for synthetic DNA orders. DNA synthesis screening is critical for preventing the building blocks of potentially dangerous pathogens from falling into the hands of malicious actors.

The Technical Consortium’s comment—signed by leading technical and policy experts from biotechnology industry, the academic research community, and the biosecurity community—expresses support for many aspects of the Revised Guidance, noting “[we] applaud the U.S. government for releasing this Revised Guidance and opening an important, valuable discussion on these challenging topics.” The comment recommends a dual-track strategy to expand biosecurity screening practices to providers who don’t currently screen and improve such practices among responsible providers.

The Technical Consortium continues to work toward the development of an international Common Mechanism for DNA synthesis screening—with plans to establish initial operational capabilities by late 2022—and it is well positioned to provide technical feedback as well as perspectives from industry and the international community. As the testing and dissemination of the Common Mechanism moves forward, the Technical Consortium will continue its efforts to ensure that its approach is consistent with this Revised Guidance and that its screening tool evolves to keep pace with rapid bioscience and biotechnology advances.

The comment was signed by the following Technical Consortium convenors and experts:

• Jaime Yassif, Vice President, NTI Global Biological Policy and Programs
• Sarah R. Carter, Science Policy Consulting
• Nicole Wheeler, University of Birmingham
• Brittany Magalis, University of Florida
• Chris Isaac, NTI Global Biological Policy and Programs

• Patrick Cai, University of Manchester
• James Diggans, Head of Biosecurity, Twist Bioscience
• Wilmot James, Columbia University
• Dan Lin-Arlow, CEO, Ansa Biotechnologies
• Miao Lu, Director of Project Management, Azenta Life Sciences
• Colin McCracken, CEO, Evonetix Ltd
• Nnaemeka Ndodo, Chief Molecular Bioengineer, Nigeria CDC
• Yue Shen, Chief Scientist of Synthetic Biology, BGI-Research
• Axel Trefzer, Director of Product Management Synthetic Biology, Thermo Fisher Scientific
• Xun Xu, CEO, BGI-Research
• Thomas Ybert, CEO, DNA Script