Managing regulatory issues arising from new diagnostic technologies: High throughput sequencing as a case study

Abstract New diagnostic technologies such as high throughput sequencing (HTS) are powerful tools that are used to detect and identify a broad range of biological organisms. As a relatively new diagnostic technology, HTS generates large volumes of data in multiple formats that require technical expertise to interpret and action accurately. Significantly, HTS can detect previously unknown organisms, often with no known associated biological parameters. Caution is required by regulatory authorities; guidelines and decision making flowcharts need to be developed to ensure appropriate and consistent diagnoses and consistent and confident decision making. This article explores the challenges involved in making regulatory decisions based on HTS data; discusses considerations that should be accounted for when managing these regulatory issues; makes suggestions to inform regulatory decisions; and presents case studies that demonstrate the potential advantages of HTS in identifying various plant pests, and the associated regulatory implications. Three categories of HTS-related diagnostics from which regulatory actions are drawn include: detecting specific pests; screening plants with symptoms but no known pests detected using conventional methods or without any prior screening; and screening plants that do not show obvious symptoms, and where the intent of the diagnostic method is investigational or regulatory in nature, such as demonstrating freedom from a regulated pest for market access.