title: Molecular Biomarkers for the Evaluation of Colorectal Cancer: Guideline From the American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and American Society of Clinical Oncology.
abstract: 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.
  
  
  
  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.
  
  
  
  Twenty-one guideline statements were established.
  
  
  
  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. Key Words: Molecular diagnostics; Gastrointestinal; Histology; Genetics; Oncology.
authors.affiliation: Department of Pathology and Cell Biology, Columbia University, New York, NY. Electronic address: as4400@cumc.columbia.edu.
authors.forename: Antonia R
authors.initials: AR
authors.lastname: Sepulveda
authors.affiliation: Department of Pathology, University of Texas MD Anderson Cancer Center, Houston.
authors.forename: Stanley R
authors.initials: SR
authors.lastname: Hamilton
authors.affiliation: Division of Hematology and Oncology, University of Florida Medical Center, Gainesville.
authors.forename: Carmen J
authors.initials: CJ
authors.lastname: Allegra
authors.affiliation: Departments of Pathology and Laboratory Medicine, Pediatrics, and Human Genetics, UCLA Medical Center, Los Angeles, CA.
authors.forename: Wayne
authors.initials: W
authors.lastname: Grody
authors.affiliation: Department of Pathology and Microbiology, University of Nebraska Medical Center, Omaha.
authors.forename: Allison M
authors.initials: AM
authors.lastname: Cushman-Vokoun
authors.affiliation: Department of Pathology and Laboratory Medicine, University of North Carolina School of Medicine, Chapel Hill.
authors.forename: William K
authors.initials: WK
authors.lastname: Funkhouser
authors.affiliation: Department of Gastrointestinal (GI) Medical Oncology, University of Texas MD Anderson Cancer Center, Houston.
authors.forename: Scott E
authors.initials: SE
authors.lastname: Kopetz
authors.affiliation: Division of Medical Oncology, University of Colorado Denver School of Medicine, Denver.
authors.forename: Christopher
authors.initials: C
authors.lastname: Lieu
authors.affiliation: Department of Medical Genetics, Mayo Clinic, Scottsdale, AZ.
authors.forename: Noralane M
authors.initials: NM
authors.lastname: Lindor
authors.affiliation: Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston.
authors.forename: Bruce D
authors.initials: BD
authors.lastname: Minsky
authors.affiliation: Castle Biosciences, Friendswood, TX.
authors.forename: Federico A
authors.initials: FA
authors.lastname: Monzon
authors.affiliation: Department of Health Sciences Research, Mayo Clinic, Rochester, MN.
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Sargent
authors.affiliation: Biocept, San Diego, CA.
authors.forename: Veena M
authors.initials: VM
authors.lastname: Singh
authors.affiliation: Department of Pathology, Case Western Reserve University, Cleveland, OH.
authors.forename: Joseph
authors.initials: J
authors.lastname: Willis
authors.affiliation: ASCP Institute for Science, Technology, and Policy, American Society for Clinical Pathology, Washington, DC.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Clark
authors.affiliation: Laboratory and Pathology Quality Center, College of American Pathologists, Northfield, IL.
authors.forename: Carol
authors.initials: C
authors.lastname: Colasacco
authors.affiliation: American Society of Clinical Oncology, Alexandria, VA.
authors.forename: R Bryan
authors.initials: RB
authors.lastname: Rumble
authors.affiliation: Association for Molecular Pathology, Bethesda, MD.
authors.forename: Robyn
authors.initials: R
authors.lastname: Temple-Smolkin
authors.affiliation: Laboratory and Pathology Quality Center, College of American Pathologists, Northfield, IL.
authors.forename: Christina B
authors.initials: CB
authors.lastname: Ventura
authors.affiliation: Department of Pathology and Laboratory Medicine, Roswell Park Cancer Institute, Buffalo, NY.
authors.forename: Jan A
authors.initials: JA
authors.lastname: Nowak
mesh_terms: D006801:Humans; D014408:Biomarkers, Tumor; D015179:Colorectal Neoplasms / Q000175:diagnosis / Q000188:drug therapy / Q000235:genetics / Q000401:mortality; D019468:Disease Management; D005787:Gene Frequency; D042822:Genomic Instability; D025202:Molecular Diagnostic Techniques; D058990:Molecular Targeted Therapy; D009154:Mutation; D059645:Mutation Rate; D011379:Prognosis; D015398:Signal Transduction; D016896:Treatment Outcome; D000078202:Systematic Reviews as Topic; D015201:Meta-Analysis as Topic
chemical_list: D014408:Biomarkers, Tumor