DecisionDx®-Melanoma Clinical Validation
Stratify by Risk of Recurrence
What is the risk of recurrence (follow up, imaging and referral decisions)?
Likelihood of
SLNB Positivity
What is the risk for a positive sentinel lymph node (SLN) among eligible patients with T1-T4 melanoma?
Stratify by Risk of Recurrence
DecisionDx-Melanoma Clinical Validation to Stratify by Risk of Recurrence
Accuracy of the DecisionDx-Melanoma test to determine risk of recurrence and metastasis in patients with cutaneous melanoma has been evaluated in three prospectively designed studies that have been combined in a total validation cohort of 690 patients (Gastman 2019; Gerami 2015a; Gerami 2015b; Zager 2018). Key results from the combined validation cohort include:
- DecisionDx-Melanoma was an independent predictor of recurrence-free survival (RFS), DMFS and MSS with five-year survival rates for patients with a Class 1A result significantly higher than patients with the Class 2B result (p<0.0001).
- DecisionDx-Melanoma shows negative predictive value (NPV) for MSS of 99%, providing confidence in melanoma management decisions based on test results.
- This validation cohort was included in a meta-analysis that demonstrated DecisionDx-Melanoma is an independent predictor of outcomes with an accuracy that improves upon current staging.
DecisionDx-Melanoma 31- GEP testing uses tumor biology to refine risk stratification beyond what is available through traditional staging alone.
Order DecisionDx®-Melanoma
NOW AVAILABLE: New Integrated Test Result for Precise and Personalized Risk of Recurrence
Expert Opinions in Melanoma
Improving Patient Selection for the SLNB Surgical Procedure
On-Demand
Educational Programs
Individualized Risk of Recurrence
DecisionDx-Melanoma is the only melanoma prognostic test to offer individualized assessment for risk of recurrence or metastasis.
Understanding that every patient is unique, to better identify patients’ individual risk of recurrence or metastasis the DecisionDx-Melanoma Class score was integrated with a patients clinicopathological features to create an individualized risk of recurrence or metastasis. This new algorithmic approach is the only GEP validated to provide this type of precision risk estimate.
DecisionDx-Melanoma now combines 31-GEP Class score with clinicopathological features to provide an individualized risk of recurrence or metastasis.
Likelihood of SLNB Positivity
Limitations of SLNB as a Prognostic Indicator
While guidelines recommend that SLNB be considered for patients with T1b tumors and above, as well as T1a tumors with high-risk features, 88% of patients will have a negative result. The SLNB procedure carries with it significant additional limitations including no survival benefit (Morton 2014), false-negative rates between 5-21% and exposure to anesthesia risks and a surgical complication rate of 11% (Moody 2016).
