The leader 
in prognostic melanoma testing

Guide your melanoma management with the most clinically validated and comprehensive GEP test on the market.

What is DecisionDx-Melanoma?

   

DecisionDx-Melanoma is the only melanoma gene expression profiling (GEP) test associated with improved survival.1

The test provides personalized results for patients with stage I-III cutaneous melanoma, guiding risk-aligned management decisions. By integrating the GEP score with traditional clinicopathologic features, DecisionDx-Melanoma results provide comprehensive results to answer two critical questions:

  • 1

    What is my patient's likelihood of sentinel lymph node (SLN) positivity?

    The validated i31-SLNB algorithm integrates the 31-GEP score with specific clinicopathologic factors of Breslow thickness, ulceration, mitotic rate, and age. It provides a personalized risk assessment for the likelihood of having a positive node.2

  • 2

    What is my patient's risk of recurrence or metastasis?

    The validated i31-ROR algorithm integrates the 31-GEP score with specific clinicopathologic factors of Breslow thickness, ulceration, mitotic rate, SLN status,age, and binned tumor location. It provides a personalized 5-year outcomes for melanoma-specific survival, distant metastasis-free survival, and recurrence-free survival.3

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Clinically validated in the largest real-world study of GEP testing in melanoma

   

Recent data from an ongoing collaboration with the National Cancer Institute’s Surveillance, Epidemiology and End Results (SEER) Program show that DecisionDx-Melanoma testing was associated with lower melanoma-specific and overall mortality compared to untested patients. The study confirms DecisionDx-Melanoma delivers significant, independent risk stratification beyond AJCC8 staging.1

29% Lower 3-year melanoma-specific mortality rate in patients clinically tested vs. untested 17% Lower 3-year overall mortality rate in patients clinically tested vs. untested

Independently validated. Clinically tested.

To validate any algorithm, multivariate analysis is standard practice and is needed as it shows you which factors are predictive. Without this analysis, it's impossible to determine which variables are driving performance. 

If you're going to use a GEP test in clinical practice, it's critical to ensure that the test provides clear, independent value beyond what's already freely and readily available to you today—namely, American Joint Committee on Cancer (AJCC) staging.

DecisionDx-Melanoma has nine peer-reviewed studies demonstrating consistent, independent performance – no other GEP test in melanoma has such evidence. 

Other GEP tests
Studies with multivariate analysis demonstrating independent prognostic value of GEP compared to AJCC stage Gerami, et al. 2015
Ferris, et al. 2017
Podlipnik, et al. 2019
Gastman, et al. 2019.
Hsueh, et al. 2021
Jarrell, et al. 2021
Arnot, et al. 2021
Bailey, et al. 2023
Podlipnik, et al. 2024		 None
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Sentinel lymph node biopsy guidance you can trust

   

A recent study by Peter A. Prieto, MD, MPH, Laura K. Ferris, MD, PhD, and J. Michael Guenther, MD, published in Cancer Diagnosis & Prognosis, compared 31-GEP and CP-GEP for SLNB decision-making, analyzing five CP-GEP validation studies and four 31-GEP studies in T1-T2 tumors.

  • KEY TAKEAWAY

    CP-GEP identified low-risk patients with an SLN positivity rate of 6.2%, exceeding the 5% threshold used by the National Comprehensive Cancer Network (NCCN) for SLNB decisions. 

  • KEY TAKEAWAY

    In contrast, DecisionDx-Melanoma shows a 2.8% SLN positivity rate among low-risk patients, well below the 5% threshold and in line with clinical expectations. 

Overall, that data show that CP-GEP did not perform as well as AJCC, while DecisionDx-Melanoma performed better than AJCC4

GEP Test True Negative: False Negative Ratio False-Negative Rate Reference
CP-GEP
T1-T2 12:1 7.9% Mulder, et al. 2020
T1-T2 27:1 3.5% Johansson, et al. 2021
T1-T2 15:1 6.3% Yousaf, et al. 2021
T1-T2 27:1 3.5% Stassen, et al. 2023
T1-T2 14:1 6.8% Sondak, et al. 2024
CP-GEP T1-T2 Overall 15:1 6.2%
31-GEP/ i31-SLNB
T1-T2 (31-GEP) 34:1 3.0% Yamamoto, et al. 2023
T1-T2 (i31-SLNB)b 25:1 3.9% Whitman, et al. 2021
T1-T2 (i31-SLNB) 30:0 0% Kriza, et al. 2024
T1-T2a (i31-SLNB) 58:0 0% Beard, et al. 2024
31-GEP/ i31-SLNB T1-T2 Overall 34:1 2.8%

Ultimately, “low risk” CP-GEP results are simply not low enough.

DecisionDx-Melanoma provides significant risk-stratification to inform management decisions 

The visual on the right highlights the meaningful risk stratification between a Class 1A (lowest risk) and Class 2B (highest risk) DecisionDx-Melanoma result.

How does DecisionDx-Melanoma compare to other GEP tests?
Other GEP tests report a 74% recurrence-free survival (RFS) rate in their high-risk category, while reporting an 89% RFS in their low-risk population9. Notably, an 89% RFS is a threshold many oncologists would still consider the risk significant enough to warrant adjuvant therapy.10

   

I want to order DecisionDx-Melanoma

Expert Insights: Discover why Shannon Trotter, DO, FAOCD, FAAD, chooses DecisionDx-Melanoma and how it enhances patient management

Castle Biosciences: The leader in melanoma prognostic testing leader with independent, robust validation and real-world results

50+

peer-reviewed, pubished studies including prospective studies and two meta-analyses

200k+

patients with a clinical DecisionDx-Melanoma order from ~13,000 clinicians

Medicare+

covered by Medicare and multiple private insurers with an industry-leading patient assistance program

*Numbers as of May 2025

Ensure you’re using DecisionDx-Melanoma—the most clinically evidenced GEP test—to guide management decisions for your melanoma patients

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References

  1. Bailey et al. JCO PO. 2023
  2. Whitman et al. JCO PO. 2021
  3. Jarell et al. JAAD. 2022
  4. Prieto et al. Cancer Diagnosis & Prognosis. 2025
  5. Gerami et al. Clin Cancer Res. 2015
  6. Gerami et al. JAAD. 2015
  7. Zager et al. BMC Cancer. 2018
  8. Gastman et al. JAAD. 2019
  9. Eggermont et al. EJC. 2020
  10. Fastner et al. Cancer Medicine. 2023