# Molecular biomarkers for the evaluation of colorectal cancer: guideline from ASCP, CAP, AMP and ASCO

Source: https://onco.cc/key-papers/paper-sepulveda-molecular-biomarkers-colorectal-guideline-jco-2017/  
OnCo record `paper-sepulveda-molecular-biomarkers-colorectal-guideline-jco-2017` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The guideline that says which genes must be tested in every bowel cancer, on what sample, and how quickly: extended RAS and BRAF to decide on EGFR antibodies, and mismatch repair on every tumour.

## Summary

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 evidence-based recommendations for molecular biomarker testing in colorectal cancer, drawing on a systematic review of more than 4,000 articles. Twenty-one guideline statements were established: eight recommendations, ten expert consensus opinions and three areas where no recommendation could be made. The evidence supports mutational testing for genes in the EGFR signalling pathway, since they provide clinically actionable information as negative predictors of benefit from anti-EGFR monoclonal antibody therapy, and several biomarkers carry clear prognostic value. Laboratory recommendations cover assay selection, specimen type, when tests should be ordered and acceptable turnaround times.

## Fields

- Kind: Key paper
- Last checked: 2026-09-24
- Journal: Journal of Clinical Oncology
- Year: 2017
- DOI: 10.1200/JCO.2016.71.9807
- Authors: Sepulveda AR, Hamilton SR, Allegra CJ, et al.
- Findings: Extended RAS (KRAS and NRAS exons 2, 3 and 4) testing is required before EGFR antibody therapy.; BRAF V600 testing for prognosis and, with mismatch repair, for Lynch syndrome evaluation.; Mismatch repair status should be determined on all colorectal cancers.
- What it means: It is the reference for what a colorectal molecular report must contain, and the document that turned extended RAS from a trial finding into a requirement.
- Caveats: Published in 2017, so HER2, NTRK, RET and tumour mutational burden are not covered as they would be now.; Recommendations about turnaround time and assay choice are aspirational in many health systems.

## Sources

- Sepulveda et al., J Clin Oncol 2017: ASCP, CAP, AMP and ASCO guideline on molecular biomarkers for colorectal cancer: https://doi.org/10.1200/JCO.2016.71.9807
- PubMed: https://pubmed.ncbi.nlm.nih.gov/28165299/

## Connected records

- cancers: [Colorectal cancer](https://onco.cc/cancers/colorectal/)
- technologies: [Companion diagnostics](https://onco.cc/technologies/companion-diagnostic/), [Comprehensive genomic profiling](https://onco.cc/technologies/cgp/), [Histopathology & immunohistochemistry](https://onco.cc/technologies/histopathology-ihc/), [MSI and mismatch-repair testing](https://onco.cc/technologies/msi-mmr-testing/)
- targets: [BRAF](https://onco.cc/targets/braf/), [EGFR](https://onco.cc/targets/egfr/), [KRAS](https://onco.cc/targets/kras/), [Mismatch repair proteins (MLH1, MSH2, MSH6, PMS2)](https://onco.cc/targets/mmr/), [NRAS](https://onco.cc/targets/nras/)
- terms: [Immunohistochemistry (IHC)](https://onco.cc/terms/ihc/), [Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR)](https://onco.cc/terms/msi/), [Next-generation sequencing (NGS)](https://onco.cc/terms/ngs/), [Wild-type (WT)](https://onco.cc/terms/wild-type/)
- people: [Scott Kopetz](https://onco.cc/people/scott-kopetz/)
- journals: [Journal of Clinical Oncology](https://onco.cc/journals/jco/)
- drugs: [FoundationOne CDx / Liquid CDx](https://onco.cc/drugs/foundationone-cdx/), [MI Cancer Seek](https://onco.cc/drugs/caris-mi-cancer-seek/), [Tempus xT CDx](https://onco.cc/drugs/tempus-xt-cdx/), [VENTANA MMR RxDx Panel](https://onco.cc/drugs/ventana-mmr-rxdx/)
- biomarkers: [dMMR (mismatch repair deficiency by IHC)](https://onco.cc/biomarkers/dmmr-ihc/)

---
JSON: https://onco.cc/api/v1/entities/paper-sepulveda-molecular-biomarkers-colorectal-guideline-jco-2017.json