A window into clinical next-generation sequencing-based oncology testing practices

Rakesh Nagarajan*, Angela N. Bartley, Julia A. Bridge, Lawrence J. Jennings, Suzanne Kamel-Reid, Annette Kim, Alexander J. Lazar, Neal I. Lindeman, Joel Moncur, Alex J. Rai, Mark J. Routbort, Patricia Vasalos, Jason D. Merker

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

24 Scopus citations


Context: Detection of acquired variants in cancer is a paradigm of precision medicine, yet little has been reported about clinical laboratory practices across a broad range of laboratories. Objective: To use College of American Pathologists proficiency testing survey results to report on the results from surveys on next-generation sequencing-based oncology testing practices. Design: College of American Pathologists proficiency testing survey results from more than 250 laboratories currently performing molecular oncology testing were used to determine laboratory trends in next-generation sequencing-based oncology testing. Results: These presented data provide key information about the number of laboratories that currently offer or are planning to offer next-generation sequencing-based oncology testing. Furthermore, we present data from 60 laboratories performing next-generation sequencing-based oncology testing regarding specimen requirements and assay characteristics. The findings indicate that most laboratories are performing tumor-only targeted sequencing to detect single-nucleotide variants and small insertions and deletions, using desktop sequencers and predesigned commercial kits. Despite these trends, a diversity of approaches to testing exists. Conclusions: This information should be useful to further inform a variety of topics, including national discussions involving clinical laboratory quality systems, regulation and oversight of next-generation sequencing-based oncology testing, and precision oncology efforts in a data-driven manner.

Original languageEnglish
Pages (from-to)1679-1685
Number of pages7
JournalArchives of Pathology and Laboratory Medicine
Issue number12
StatePublished - Dec 2017
Externally publishedYes


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