Molecular Biomarkers for the Evaluation of Colorectal Cancer.
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.
From the Department of Pathology and Cell Biology, Columbia University, New York, NY; Departments of.
Antonia R
AR
Sepulveda
Pathology.
Stanley R
SR
Hamilton
Division of Hematology and Oncology, University of Florida Medical Center, Gainesville.
Carmen J
CJ
Allegra
Departments of Pathology and Laboratory Medicine, Pediatrics, and Human Genetics UCLA Medical Center, Los Angeles, CA.
Wayne
W
Grody
Department of Pathology and Microbiology, University of Nebraska Medical Center, Omaha.
Allison M
AM
Cushman-Vokoun
Department of Pathology and Laboratory Medicine, University of North Carolina School of Medicine, Chapel Hill.
William K
WK
Funkhouser
Gastrointestinal (GI) Medical Oncology.
Scott E
SE
Kopetz
Division of Medical Oncology, University of Colorado Denver School of Medicine, Denver.
Christopher
C
Lieu
Department of Medical Genetics, Mayo Clinic, Scottsdale, AZ.
Noralane M
NM
Lindor
Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston.
Bruce D
BD
Minsky
Castle Biosciences, Friendswood, TX.
Federico A
FA
Monzon
Department of Health Sciences Research, Mayo Clinic, Rochester, MN.
Daniel J
DJ
Sargent
Biocept, San Diego, CA.
Veena M
VM
Singh
Department of Pathology, Case Western Reserve University, Cleveland, OH.
Joseph
J
Willis
ASCP Institute for Science, Technology, and Policy, American Society for Clinical Pathology, Washington, DC.
Jennifer
J
Clark
Laboratory and Pathology Quality Center, College of American Pathologists, Northfield, IL.
Carol
C
Colasacco
American Society of Clinical Oncology, Alexandria, VA.
R Bryan
RB
Rumble
Association for Molecular Pathology, Bethesda, MD.
Robyn
R
Temple-Smolkin
Laboratory and Pathology Quality Center, College of American Pathologists, Northfield, IL.
Christina B
CB
Ventura
Department of Pathology and Laboratory Medicine, Roswell Park Cancer Institute, Buffalo, NY.
Jan A
JA
Nowak
D006801:Humans; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D014408:Biomarkers, Tumor; D015179:Colorectal Neoplasms / Q000175:diagnosis / Q000628:therapy; D066246:ErbB Receptors; D000078202:Systematic Reviews as Topic
D000911:Antibodies, Monoclonal; D014408:Biomarkers, Tumor; D066246:ErbB Receptors