An extensively-researched approach for risk stratification
DecisionDx-Melanoma is strongly evidenced in more than 40 peer-reviewed publications and has been studied in more than 10,000 patients. In these studies, DecisionDx-Melanoma consistently outperforms traditional staging alone in a variety of melanoma patient cohorts.
DecisionDx-Melanoma featured studies
Meta-analysis of 1,479 patients showed that DecisionDx-Melanoma consistently identified melanoma patients who were at an increased risk of metastasis, independent of traditional clinicopathologic factors, and can be used in conjunction with traditional staging to improve patient risk stratification.
PERSONALIZED RISK OF RECURRENCE (i31-ROR VALIDATION)Read More
This study validated a proprietary algorithm integrating the DecisionDx-Melanoma 31-GEP class score with clinicopathologic factors to provide personalized risk of recurrence assessment. The study showed that patients with a low-risk i31-ROR result has significantly higher 5-year survival than patients with a high-risk i31-ROR result.
LIKELIHOOD OF SENTINEL LYMPH NODE POSITIVITY (i31-SLNB VALIDATION)Read More
Validation of the neural network algorithm incorporating clinicopathologic factors with the 31-GEP class score for personalized SLNB positivity risk assessment.
- Of all factors, the 31-GEP was the most predictive of a positive SLN
- The i31-SLNB algorithm reclassified 63% of patients with T1 tumors, originally classified with a 5-10% likelihood of SLN positivity.
- Increase from 8.5% to 27.7% in patients with T1-T4 tumors predicted to have <5% SLN positive likelihood, with 98% NPV
Trusted in practice
DecisionDx-Melanoma has been ordered more than 146,000 times for patients diagnosed with cutaneous melanoma (through September 30, 2023)
healthcare professionals have ordered the test for CM
technical success rate in 53,000+ clinical samples
DecisionDx-Melanoma and NCI collaboration delivers real-world data
Castle Biosciences partners with the National Cancer Institute (NCI) in an ongoing collaboration to link DecisionDx-Melanoma testing data with data from the Surveillance, Epidemiology and End Results (SEER) Program’s registries on cutaneous melanoma cases. This helps us put our test results into perspective with current standards and to learn where it is most beneficial to patients.