A Window Into Clinical Next-Generation Sequencing-Based Oncology Testing Practices

Nagarajan, R.; Bartley, A. N.; Bridge, J. A.; Jennings, L. J.; Kamel-Reid, S.; Kim, A.; Lazar, A. J.; Lindeman, N. I.; Moncur, J.; Rai, A. J.; Routbort, M. J.; Vasalos, P.; Merker, J. D.

Arch Pathol Lab Med. 2017 Oct 14; 141(12):1679-1685


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.

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