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.
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:
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 (NCI) Surveillance, Epidemiology and End Results (SEER) Program Registries show that testing with DecisionDx-Melanoma was associated with lower melanoma-specific and overall mortality relative to untested patients. In the study, DecisionDx-Melanoma provided significant and independent risk stratification of patients with cutaneous melanoma, beyond American Joint Committee on Cancer Eighth Edition (AJCC8) stage, which may help inform more personalized patient management decisions.3
Clinically proven to improve outcomes
A recent independent, multi-center study of SLN negative patients explored the utility of routine imaging to detect metastases in patients with a negative sentinel lymph node biopsy but high risk DecisionDx-Melanoma results. This retrospective analysis of clinically tested patients was performed at 3 NCI-designated cancer centers (Northwestern University, Cleveland Clinic, and Oregon Health & Science University), and included patients with confirmed melanoma diagnosis and negative SLNB.
The experimental group (n=307) included the high risk DecisionDx-Melanoma patients, and physicians used the results to guide their melanoma management. The control group (n=327) consisted of patients who did not receive DecisionDx-Melanoma testing, and their management was based on symptoms or exam findings.
The conclusion? Patients who received routine imaging after high-risk GEP test scores had an earlier recurrence diagnosis with lower tumor burden, which was associated with better clinical outcomes.4
DecisionDx-Melanoma accurately identifies truly low-risk patients
A recent prospective, multicenter study demonstrated:1,5
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Using DecisionDx-Melanoma to guide management decisions reduced SLNBs performed by 18.6%
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No patient with an SLNB predicted risk of <5% positivity who underwent the procedure had a positive node
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No Class 1A (low-risk) patients have experienced a recurrence‡
‡ Median follow up time of two years
Not all GEP tests are created equal
The value of a test is driven by the value of information it provides. DecisionDx-Melanoma has continued to show that it offers data that is above and beyond what traditional staging can provide.
 |
Other GEP tests | |
| Identifies patient risk for nodal metastasis | ✔ | ✔ |
| Provides personalized risk for sentinel lymph node positivity | ✔ | x |
| Provides personalized risk of recurrence including MSS, RFS, and DMFS | ✔ | x |
| Data demonstrates independent, significant risk stratification provided by GEP result compared to AJCC stage | ✔ | x |
| Data demonstrates improved patient survival associated with testing | ✔ | x |
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DecisionDx-Melanoma provides a comprehensive,
personalized resultA: Class result and GEP score
Classification of GEP as a Class Result & GEP Score for risk of recurrence and/or metastasis within five years. Results are reported as:
- Class 1A - Lowest Risk (0 to 0.41)
- Class 1B/2A - Increased Risk (>0.41 to <0.59)
- Class 2B - Highest Risk (0.59 to 1.0)
B: Personalized risk of recurrence estimates
The validated i31-ROR algorithm integrates the 31-GEP score with the patient's specific clinicopathologic factors of Breslow thickness, ulceration, mitotic rate, SLN status, age and binned tumor location. Personalized 5-year outcomes for three distinct endpoints are reported:
- Melanoma-Specific Survival (MSS)
- Distant-Metastasis Free Survival (DMFS)
- Recurrence-Free Survival (RFS)
C: Personalized likelihood of sentinel lymph node positivity
The validated i31-SLNB algorithm integrates the 31-GEP score with the patient's specific clinicopathological factors of Breslow thickness, ulceration, mitotic rate, and age. It provides a personalized risk assessment for the likelihood of having a positive sentinel lymph node biopsy (SLNB).
This information will not be reported if a SLNB has already been performed.
Hear from an expert: How Mark Gimbel, MD uses DecisionDx-Melanoma to personalize care
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Dr. Gimbel, a surgical oncologist specializing in melanoma, discusses how he integrates DecisionDx-Melanoma into his daily practice. Watch the video to see how an expert uses this powerful prognostic tool to guide treatment decisions and enhance patient care at every step in their journey.
Castle Biosciences: The leader in melanoma prognostic testing leader with independent, robust validation and real-world results
i31-Precision
validated AI-driven algorithms integrating 31-GEP with patient-specific clinicopathologic factors
50+
peer-reviewed, pubished studies including prospective studies and two meta-analyses
>10,000
patients studied including independent validation
150,000+
patients with a clinical DecisionDx-Melanoma order from ~13,000 clinicians
50%
demonstrated clinical utility providing change in management for one of two patients tested
Medicare+
covered by Medicare and multiple private insurers with an industry-leading patient assistance program
*Numbers as of February 2024
Ready to enhance your decision making and improve patient outcomes?
References
- Guenther, JM, et al. Society of Surgical Oncology SSO 2024 Annual Meeting. Ann Surg Oncol. 31 (Suppl 1), S32 (2024).
- Jarell, et al. JAAD. 2022.
- Bailey et al. JCO PO. 2023
- Dhillon et al., Archives of Derm Research. 2023.
- Yamamoto et al, CMRO. 2023.