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What the Research Says.
From the Organizations
That Do It.

GCCA curates published research and guidelines from leading oncology sources on biomarker testing in colorectal cancer.

research and guidelines

From Trusted Oncology Sources

Source
esmo.org
Guideline
European Society for Medical oncology

Supports comprehensive biomarker testing for mCRC

The European Society for Medical Oncology recommends that all patients with metastatic colorectal cancer receive comprehensive biomarker testing at diagnosis to guide treatment decisions. At a minimum, this includes testing for RAS (KRAS/NRAS), BRAF V600E, and mismatch repair or microsatellite instability (MMR/MSI) status, with additional biomarkers such as HER2 and NTRK fusions increasingly recommended as part of broader genomic profiling. These biomarkers help determine eligibility for targeted therapies and immunotherapy, and testing should be performed as early as possible using tumor tissue or, when needed, liquid biopsy, ensuring treatment is tailored to the tumor’s molecular profile from the start.

View ESMO Guideline
Source
nccn.org
guideline
National Comprehensive Cancer Network

Biomarker testing impacts therapy

According to the National Comprehensive Cancer Network, biomarker testing is a critical step in the initial workup for metastatic colorectal cancer and should be completed upfront to inform treatment planning. Core testing includes RAS (KRAS and NRAS), BRAF V600E, and mismatch repair or microsatellite instability (MMR/MSI) status, which directly impact therapy selection. NCCN also supports the use of broader genomic profiling, typically through next-generation sequencing, to identify less common but actionable alterations such as HER2 amplification and NTRK fusions. When tumor tissue is unavailable or insufficient, liquid biopsy may be used, helping ensure patients have access to targeted treatments and appropriate clinical trial options.

View NCCN Guideline
Source
personalizedmedicinecoalition.org
Research
personalized medicine coalition

Clinical trial biomarker requirements rising sharply

Personalized Medicine Coalition data shows that over 55% of oncology clinical trials in 2018 required biomarker data for patient eligibility, up from approximately 15% in 2000.

55%+of oncology trials required biomarker testing
15%of oncology trials required biomarkers in 2000
Read the Article
Source
ema.europa.eu
guideline
European Medicines Agency — DPD/DPYD

DPYD testing is standard of care in Europe — DPD deficiency can cause fatal 5-FU toxicity

The European Medicines Agency (EMA) recommends pre-treatment DPYD testing in patients receiving fluoropyrimidine chemotherapy. DPD deficiency affects an estimated 3–9% of patients and can cause fatal or life-threatening toxic reactions.

See Troy & Jodi’s story
View EMA Guideline
Source
jamanetwork.com
Research
Biomarker Testing Disparities

Real-world data reveals a stark gap between guidelines and practice

This cohort study was based on 41,000 patients' data from the National Cancer Database. The main outcomes were MSI and KRAS testing between the date of diagnosis and the date of first-course therapy.

Read the Article

Missed Opportunities: The Full Picture

Patients are missing critical opportunities to receive personalized colorectal cancer care. Real-world data tells the story: in rural oncology settings, ordering rates for guideline-recommended biomarkers (KRAS, NRAS, BRAF, HER2, MSI/MMR) fall well below standards. In actual medical records, the gap is even wider than self-reported numbers suggest.

“When it comes to colorectal cancer, waiting for the right information isn’t hesitation — it’s precision.”

The natural inclination is to act immediately. But acting without biomarker results can mean missing the most effective targeted therapies, or losing eligibility for a clinical trial entirely. That window isn't delay. It's the foundation of personalized care.

Oncogene illustration from Know Your Biomarker: HER2