A Case Study of Next-Generation Sequencing Operationalization in an Oncology Companion Diagnostic Environment

Abstract

The rise of utilization of next-generation sequencing (NGS) tests in the clinical practice and drug development settings has increased the need for additional regulatory oversight and company practices to support the growth. The operational effects of next-generation sequencing tests, from both the regulatory and growth burden is largely undervalued during the test development process. As such, if the operational components that affect the scalability and success of a product can be classified, there is a higher likelihood of the overall clinical adoption and FDA approval success. This study focuses on the regulatory oversight of next-generation sequencing tests and the components of the product that can affect the operational outcomes. Through the review of current FDA Medical Device regulations and comparison to other categories of regulated products, the overall regulatory needs and opportunities for improved oversight can be achieved. Furthermore, by review of the technical, performance, and operational criteria of currently approved NGS tests, an overall predictive model can be generated to offer perspectives into the regulatory, development, and operational components of non-FDA approved tests. Through this review, via a comprehensive analysis of the regulatory requirements, assay specifications, and operational components of next-generation sequencing tests, a viable model for the prediction of clinical adoption and FDA approval was generated.