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Summary

Description
English: "No governments currently require screening or mandate how it is performed, so any companies performing screening of DNA synthesis orders today do so voluntarily. In 2010, the US Department of Health and Human Services (HHS) issued the “Screening Framework Guidance for Providers of Synthetic Double-stranded DNA (https://www.phe.gov/Preparedness/legal/guidance/syndna/Documents/syndna-guidance.pdf)” to provide a high-level framework to DNA providers on how to screen orders. The Guidance states that dsDNA providers should implement customer and sequence screening and perform follow-up screening if the customer or sequence screening raises a concern (Figure 1). In issuing its guidance, HHS defined several key characteristics of each step but allowed flexibility in how organizations implemented this screening. In 2022, HHS released a proposed revision to the guidance (https://www.federalregister.gov/d/2022-09210) that expands the reach of the 2010 guidance to oligonucleotides and a wider range of potentially hazardous sequences. The International Gene Synthesis Consortium (IGSC), a group of gene synthesis providers, published the IGSC “Harmonized Screening Protocol (International Gene Synthesis Consortium. Harmonized Screening Protocol v2.0. 2017. Available: https://genesynthesisconsortium.org/wp-content/uploads/IGSCHarmonizedProtocol11-21-17.pdf)” in 2010. This protocol aligned with the 2010 guidance but is more detailed."
Date
Source https://www.cell.com/iscience/fulltext/S2589-0042(23)00242-0
Author

Authors of the study:

   Stefan A. Hoffmann
   James Diggans
   Douglas Densmore
   Junbiao Dai
   Tom Knight
   Emily Leproust
   Jef D. Boeke
   Nicole Wheeler
Yizhi Cai

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Captions

From the study "Safety by design: Biosafety and biosecurity in the age of synthetic genomics"

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9 February 2023

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