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

ABSTRACT:

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.

Methods

Foundational risk levels were constructed using the bioinformatic sequencing screening tool UltraSEQ. The risk levels range from high (corresponding to regulated sequences) to low (corresponding to nonregulated sequences of concern) to no-risk. A representative sequence data set (141,651 sequences) was constructed from publicly available synthetically derived sequences, and the percentage sequences in each risk level was

SUBMITTER: Gemler BT 

PROVIDER: S-EPMC11447129 | biostudies-literature | 2024 Sep

REPOSITORIES: biostudies-literature