DecisionDx^®-Melanoma Clinical Validation

NOW AVAILABLE: New Integrated Test Result (i31-ROR) for Precise and Personalized Risk of Recurrence Prediction. LEARN MORE

Clinically Validated to Improve the Accuracy of Risk Assessment

Clinical Validation to

Stratify by Risk of Recurrence

What is the risk of recurrence (follow up, imaging and referral decisions)?

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Clinical Validation for

Likelihood of
SLNB Positivity

What is the risk for a positive sentinel lymph node (SLN) among eligible patients with T1-T4 melanoma?

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Clinical Validation to

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.

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More than 70% of the patients who developed distant metastasis and died were classified as high risk (Class 2), including those who were SLNB negative.
DecisionDx-Melanoma is able to further stratify risk predicted by AJCC staging. In doing so, the test identifies truly low risk patients and those with higher risk disease than predicted by their clinicopathologic staging.
In patients with thin tumors (≤1 mm), a group considered to be low risk but who contribute substantially to mortality, 11% of patients were identified as high risk (Class 2B).
- Cox multivariate analysis showed that a Class 2B outcome in these patients with thin tumors was the only factor significantly associated with risk of recurrence (Hazard ratio 9.34 compared to Class 1A).

DecisionDx-Melanoma uses tumor biology to provide information on risk of recurrence and metastasis.

Clinical Validation for

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).

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i31-SLNB Algorithm Integrates DecisionDx-Melanoma Test Score with Clinicopathologic Factors for Likelihood of SLN Positivity

To better identify patients’ individual risk of SLNB positivity, the i31-SLNB algorithm was developed and independently validated to integrate clinicopathologic factors with the DecisionDx-Melanoma test score. This new algorithm provides a more precise and personalized likelihood of SLN positivity, identifying patients with a low risk of SLN positivity who could potentially forgo the procedure as well as those with a high risk of SLN positivity.