Abstract

Reliable and accurate next-generation sequencing (NGS) technologies have a very large promise to accelerate personalized or precision medicine. NGS-based genomic data have been exploited to better understand disease development and patient characteristics that influence response to a given therapeutic intervention. NGS-based technologies are well suited to studying disease development, progression, and emergence of resistance, all key factors in the development of next-generation disease diagnostics. NGS platforms play an important role in the way diseases will be diagnosed and drugs will be prescribed in the future. However, NGS tests report vast amounts of data, and currently much of that data is poorly understood in the context of patient care. There are a number of challenges including operational, technical, regulatory, and strategic which need to be overcome to enable a successful NGS-based precision medicine. Here, we give an overview of the available NGS sequencing technologies along with tools for data analysis. Further, we also discuss approval of NGS-based assays by the Food and Drug Administration (FDA) which covers the safety and regulatory aspects of NGS in precision medicine.

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