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 uses tumor biology to provide information on risk of recurrence and 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).

DecisionDx-Melanoma enables those with low risk of SLN positivity to avoid the procedure so resources can be focused on high-risk patients for whom the procedure is appropriate.
Order DecisionDx®-Melanoma
NOW AVAILABLE: New Integrated Test Result for Precise and Personalized Prediction of SLN Positivity
Expert Opinions in Melanoma
Improving Patient Selection for the SLNB Surgical Procedure
