Castle Biosciences' DecisionDx®-Melanoma Test Significantly Improves Risk Prediction Within AJCC Stages to Support Personalized, Risk-Aligned Management of Cutaneous Melanoma, Data to Be Presented at AAD 2026
Data from 1,868 Surveillance, Epidemiology and End Results (SEER)-linked patients show DecisionDx-Melanoma significantly stratifies five-year melanoma-specific survival within
"The findings being presented at AAD reinforce that staging alone does not tell the whole story," said
Detailed findings from this analysis will be presented in the following poster at AAD:
- ePoster: 76747 – The 31-GEP provides actionable risk stratification of 5-year melanoma specific survival rates within AJCC subgroups
- Lead Author:
Harrison Nguyen M.D., MBA, MPH, Harrison Dermatology & Research Group ,Missouri City, Texas
This poster from Castle's ongoing collaboration leveraging data from the
Traditional AJCC staging groups biologically distinct tumors based on clinicopathologic features alone, which can underestimate or overestimate a patient's true risk of poor outcomes. In this analysis, registry data from 22 SEER sites were linked to data from patients with stage I–III CM who were clinically tested with the DecisionDx-Melanoma test and had at least five years of follow up or death from their disease (n=1,868; 2013–2019). The test significantly stratified five-year melanoma-specific survival (MSS) within T categories and AJCC substages. In patients with T1 tumors, five-year MSS was 96.7% for those with low-risk (Class 1A) results versus 70.0% for high-risk (Class 2B) results, and among patients with Stage IIB–III disease, MSS was 87.4% for low-risk versus 48.5% for high-risk results (log-rank test; p<0.05).
Overall, the data show that DecisionDx-Melanoma can identify patients at higher or lower risk than predicted by AJCC staging alone, including high-risk T1 (thin) tumors with mortality risk approaching that of thicker melanomas, while also distinguishing lower-risk patients who may be appropriate for less intensive follow-up. These findings support integrating DecisionDx-Melanoma with staging to inform more precise, risk-aligned management decisions for patients with CM.
Full abstract content will be available in the AAD online viewing portal and onsite at the viewing stations beginning at the start of the meeting. They will also be published online via the
About DecisionDx-Melanoma
DecisionDx-Melanoma is a gene expression profile (GEP) test designed to analyze tumor biology to deliver a personalized risk assessment for patients with stage I–III cutaneous melanoma, enhancing risk stratification beyond
DecisionDx-Melanoma is supported by more than 50 peer-reviewed publications, including prospective studies and meta-analyses, and was developed in collaboration with more than 100 leading
About
We put people first—empowering patients and clinicians and informing care decisions through rigorous science and advanced molecular tests that support more confident treatment planning. To learn more, visit www.CastleBiosciences.com and connect with us on LinkedIn, Instagram, Facebook and X.
DecisionDx-Melanoma, DecisionDx-CMSeq, i31-SLNB, i31-ROR, DecisionDx-SCC, MyPath Melanoma, AdvanceAD-Tx, TissueCypher, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq are trademarks of
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the "safe harbor" created by those sections. These forward-looking statements include, but are not limited to, statements concerning: the ability of DecisionDx-Melanoma to (i) help clinicians more confidently
escalate care for higher-risk patients while avoiding unnecessary interventions in those at lower risk of poor outcomes;(ii) identify patients at higher or lower risk than predicted by AJCC staging alone, including high-risk T1 (thin) tumors with mortality risk approaching that of thicker melanomas; and (iii) support more personalized management decisions by delivering a personalized risk assessment. The words "designed," "may", "can", and similar expressions are intended to identify forward intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward looking statements involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements, including, without limitation: subsequent study or trial results and findings may contradict earlier study or trial results and findings or may not support the results obtained in these studies, including with respect to the discussion of our tests in this press release; actual application of our tests may not provide the aforementioned benefits to certain patients; and the risks set forth under the heading "Risk Factors" in our Annual Report on Form 10-K for the year ended
Investor Contact:
czuckero@castlebiosciences.com
Media Contact:
amarshall@castlebiosciences.com
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