Next-generation sequencing (NGS) technology allows many genes to be sequenced at once. NGS-based tests can therefore provide a more comprehensive assessment of a cancer’s genomic profile. The technology and its applications have driven an increase in the diversity and complexity of commercially available tests for mainstream clinical use. In response to these rapid changes in cancer care, the Patient-Centered Outcomes Research Institute (PCORI) commissioned this emerging technology report to ascertain the landscape of clinical evidence documenting the impact of commercially available NGS-based multigene panel tests on the management and health outcomes of patients with cancer, termed as clinical utility.
The purpose of this report is to summarize the current state of clinical evidence supporting use of NGS-based genomic testing for guiding management of patients with cancer. This report uses technique of evidence mapping, a form of systematic methodology that uses systematic search and selection of studies for descriptively summarizing the quantity and/or quality of evidence underlying a broad topic. A major objective of evidence mapping is to identify areas or topics for which evidence is lacking (termed evidence gaps) and to summarize these findings in a visually convenient format.
Review Report (Published July 2021)
This review of commercially available next-generation sequencing tests for cancer management includes 321 published clinical research studies.
Issue Brief (Published December 2021)
This issue brief discusses the current use of genomic sequencing, regulation, and evidence, as well as the challenges and opportunities ahead.
About the Emerging Technologies and Therapeutics Reports
The Emerging Technologies and Therapeutics Reports provide timely summaries of evidence supporting new drugs, devices, and other healthcare technologies that are recently in use or may be available in the near term in the United States. The documents also identify gaps that need to be addressed for the technologies or therapeutics to move forward.