A Sensitivity Study for Interpreting Nucleic Acid Sequence Screening Regulatory and Guidance Documentation: Toward a Foundational Synthetic Nucleic Acid Sequence Screening Framework

Objectives: The primary objectives of this study were to develop an objective nucleic acid sequence screening framework and to leverage the framework for an empirical sensitivity study that measures the impact of ambiguities in regulatory and guidance documentation regarding the control of synthetic nucleic acids and screening of nucleic acid orders.