The increasing use of large panel next-generation sequencing technologies in clinical settings has facilitated the identification of pan-cancer biomarkers, which can be diagnostic, prognostic, predictive, or most importantly, actionable.


To discuss recently approved and emerging pan-cancer and multihistology biomarkers as well as testing methodologies.

Data Sources.—

The US Food and Drug Administration approval documents, National Comprehensive Cancer Network guidelines, literature, and author's own publications.


Since 2017, the US Food and Drug Administration has approved genotype-directed therapies for pan-cancer biomarkers, including microsatellite instability, neurotrophic receptor kinases fusions, and high-tumor mutation burden. Both the importance and rarity of these biomarkers have increased the prevalence of genomic profiling across solid malignancies. As an integral part of the management team of patients with advanced cancer, pathologists need to be aware of these emerging biomarkers, the therapies for which they determine eligibility, and the strengths and pitfalls of the available clinical assays.

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Author notes

Ladanyi received funding support from Loxo Oncology at Lilly and advisory board compensation from Bayer and Merck. Hechtman received research funding from Bayer and Eli Lilly as well as honoraria/consulting fees from Axiom Healthcare Strategies, WebMD, and Illumina.

The other authors have no relevant financial interest in the products or companies described in this article.