Abstract

Next-generation sequencing (NGS)-regulated tests have seen the rapid development and evolution of the regulatory space. The NGS companion diagnostic (CDx) space has been extremely dynamic and evolving, and it seems evident that we are entering a time of even further growth and impact. Successful regulatory development of NGS CDx has provided good insights into assay development and analytical validation for regulatory approval. Complex assay validation parameters have been established to build a good framework for future development.

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