DecisionDx®-Melanoma Betters Risk Stratification in Cutaneous Melanoma


The use of DecisionDx-Melanoma to guide better risk-aligned care for patients with cutaneous melanoma who are considered low-risk by staging is supported by study findings.

Image Credit: © Christoph Burgstedt

Image Credit: © Christoph Burgstedt []

For patients with stage I cutaneous melanoma, DecisionDx®-Melanoma can improve risk stratification more than American Joint Committee on Cancer (AJCC) staging alone, according to new data presented at the 19th European Association of Dermato-Oncology (EADO) Congress.1

Findings from the study showed that DecisionDx-Melanoma provided significant and independent risk stratification of patients with stage I cutaneous melanoma and showed that the test added valuable prognostic information to AJCC staging to better stratify recurrence-free survival (RFS) and melanoma-specific survival (MSS) among this patient population.

Data also revealed that patients with AJCC stage I cutaneous melanoma who had a high-risk (class 2B) DecisionDx-Melanoma test result were 5.4 times more likely to die from melanoma vs patients staged as IB according to AJCC staging.

Overall, these findings support the use of the assay to guide better risk-aligned care for patients with cancer who are considered low-risk by staging. This can be done by identifying high-risk patients who may be missed using only AJCC staging criteria.

"Patients with stage I cutaneous melanoma are considered to have a lower risk of recurrence and melanoma-specific mortality; however, due to the large number of patients diagnosed with stage I disease, this patient group accounts for the largest number of deaths from melanoma," said Sebastian Podlipnik, MD, Department of Dermatology, Hospital Clinic of Barcelona, Spain, in a press release. "As the study showed, DecisionDx-Melanoma provides more precise risk stratification over staging alone to better predict which patients have a low risk of experiencing a poor outcome and those with more aggressive tumor biology who may benefit from increased clinical surveillance."

DecisionDx-Melanoma is a gene expression profile risk stratification test designed to assess a patient’s individual risk of sentinel lymph node positivity and a patient's personal risk of melanoma recurrence and/or metastasis. Through the integration of tumor biology with clinical and pathologic factors using a validated proprietary algorithm, DecisionDx-Melanoma aims to find a comprehensive and clinically actionable result which will help clinicians guide risk-aligned patient care.

Previously, the assay has been associated with improved patient survival. DecisionDx-Melanoma has been ordered 120,287 times for patients diagnosed with cutaneous melanoma through December 31, 2022, has been studied in over 10,000 patient samples, and has had its clinical value supported by more than 40 peer-reviewed and published studies.

Already reported findings have highlighted its potential and promise in disease management plans that incorporate the test’s results. In a poster presentation at the 19th International Congress of the Society for Melanoma Research, investigators reported that DecisionDx-Melanoma can identify patients with a low-risk of death from cutaneous melanoma who could go without unnecessary adjuvant therapies.2 The poster also showed that the test can identify patients with melanoma who have a higher risk of progressing, potentially leading to more aggressive therapeutic decisions.

In this study, patients with stage IIB or IIC melanoma and a low-risk (class 1A) DecisionDx-Melanoma test result had higher melanoma-specific survival (MSS) at 3 years compared with patients with a high-risk (class 2B) result. For class 1A, the rate was 100% vs 88.3% in class 2B (P = .04). There were similar results observed for patients with stage III cutaneous melanoma as class 1A had an MSS score of 96.1% while class 2B had an MSS score of 79.6% (P = .03).

Moreover, DecisionDx-Melanoma was a statistically significant and independent predictor of MSS across all stages of disease and demonstrated a hazard ratio of 7.00 for the class 2B result.

1. DecisionDx®-Melanoma provides improved risk stratification over american joint committee on cancer (AJCC) staging alone in stage I melanoma patients. News release. Castle Biosciences, Inc. April 25, 2023. Accessed April 26, 2023.
2. Castle Biosciences presents new data from collaboration with the national cancer institute’s (NCI) surveillance, epidemiology and end results (SEER) program. News release. October 27, 2022. Accessed April 26, 2023.
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