Innocent Until Proven Guilty: The Case for Limiting 'Sequences of Concern' to Those with Demonstrated Pathogenic Function

Published

December 9, 2025

Author(s)

Gene D. Godbold, Krista Ternus, Kevin Flyangolts, Nicole Wheeler, Michael Parker, Jacob Beal, Peter Carr, KEMPER TALLEY, Caitlin Jagla, Bryan Gemler, Craig Bartling, Rebecca Mackelprang, India Hook-Barnard, James Diggans, Samuel Forry, Sheng Lin-Gibson, Tyler Laird, Todd Treangen, Tessa Alexanian, Gregory Koblentz, Kevin Esvelt, Joshua Gil

Abstract

Screening synthetic nucleic acid orders for sequences of concern is a necessary part of a healthy biosecurity regime, but it exacts costs for nucleic acid providers. Taxonomy is and will remain a critical part of the decision-making process for screening, especially for viral sequences. But, moving forward, the function of a sequence will also be determinative of its level of concern, or lack thereof. Stakeholders continue to debate which functions are "of concern." But however these are ultimately adjudicated, non-viral sequences with unknown or hypothetical functions which, by definition, can bear no resemblance to sequences with concerning functions, must be considered innocent of harmful effects. To qualify as a non-viral sequence of concern, the sequence to which it is a best match must be demonstrated in the published literature to have a function of concern.

Citation

Applied Biosafety: Journal of the American Biological Safety Association

Pub Type

Journals

Keywords

synthetic DNA screening, sequence of concern

Citation

Godbold, G. , Ternus, K. , Flyangolts, K. , Wheeler, N. , Parker, M. , Beal, J. , Carr, P. , TALLEY, K. , Jagla, C. , Gemler, B. , Bartling, C. , Mackelprang, R. , Hook-Barnard, I. , Diggans, J. , Forry, S. , Lin-Gibson, S. , Laird, T. , Treangen, T. , Alexanian, T. , Koblentz, G. , Esvelt, K. and Gil, J. (2025), Innocent Until Proven Guilty: The Case for Limiting 'Sequences of Concern' to Those with Demonstrated Pathogenic Function, Applied Biosafety: Journal of the American Biological Safety Association (Accessed December 10, 2025)