Molecular Biomarkers for the Evaluation of Colorectal Cancer

Antonia R. Sepulveda, Stanley R. Hamilton, Carmen J. Allegra, Wayne Grody, Allison M. Cushman-Vokoun, William K. Funkhouser, Scott E. Kopetz, Christopher Lieu, Noralane M. Lindor, Bruce D. Minsky, Federico A. Monzon, Daniel J. Sargent, Veena M. Singh, Joseph Willis, Jennifer Clark, Carol Colasacco, R. Bryan Rumble, Robyn Temple-Smolkin, Christina B. Ventura, Jan A. Nowak

Research output: Contribution to journalArticlepeer-review

14 Scopus citations


Objectives: To develop evidence-based guideline recommendations through a systematic review of the literature to establish standard molecular biomarker testing of colorectal cancer (CRC) tissues to guide epidermal growth factor receptor (EGFR) therapies and conventional chemotherapy regimens. Methods: The American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and American Society of Clinical Oncology convened an expert panel to develop an evidence-based guideline to establish standard molecular biomarker testing and guide therapies for patients with CRC. A comprehensive literature search that included more than 4,000 articles was conducted. Results: Twenty-one guideline statements were established. Conclusions: Evidence supports mutational testing for EGFR signaling pathway genes, since they provide clinically actionable information as negative predictors of benefit to anti-EGFR monoclonal antibody therapies for targeted therapy of CRC. Mutations in several of the biomarkers have clear prognostic value. Laboratory approaches to operationalize CRC molecular testing are presented.

Original languageEnglish (US)
Pages (from-to)221-260
Number of pages40
JournalAmerican journal of clinical pathology
Issue number3
StatePublished - Mar 1 2017


  • Molecular diagnostics
  • gastrointestinal
  • genetics
  • histology
  • oncology

ASJC Scopus subject areas

  • Pathology and Forensic Medicine


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