DecisionDx®-Melanoma Prospective Studies
Consistent Results from Prospective Risk of Recurrence Studies Support Routine Use of DecisionDx-Melanoma
Consistent results observed across six prospective clinical studies totaling 1,621 patients, showing high sensitivity and NPV, support routine use of DecisionDx-Melanoma to identify individual risk and inform clinical decisions.
Combined 1,621 patients across prospective studies
- Analysis of 322 patients from 11 dermatologic and surgical centers reported 1.5- and 3-year RFS rates of 97% (at both time points) for Class 1 patients, and 77% and 65%, respectively, for Class 2 patients (p<0.0001).
- While the majority (20 of 25) of melanoma recurrences were observed in the Class 2 group, a negative predictive value of 98% for recurrence demonstrated that a Class 1 outcome was associated with a low risk of metastasis.
- Cox regression analysis showed that DecisionDx-Melanoma was an independent and the most significant factor predicting risk of recurrence.
Thorpe et al. ASDS 2019: Independent, prospective, multicenter study showing consistent performance in dermatology practice population.
- This prospective cohort of 1,124 melanoma patients treated with Mohs surgery at 9 clinical sites demonstrated that Class 2 patients were 16 times more likely to develop metastatic disease than those with Class 1 result.
- The NPV of 98% provides confidence in low risk of metastasis and mortality for Class 1 patients and confirms the prognostic value of the DecisionDx-Melanoma test.
Keller et al. Cancer Med 2019: Prospective study of gene expression profiling shows 79% of recurrences in Class 2 patients.
- In an independent study performed at a surgical oncology practice, 159 consecutive melanoma patients undergoing sentinel lymph node (SLN) biopsy were tested with DecisionDx-Melanoma.
- With a median follow-up time of 44.9 months a total of 29 recurrences were reported, of which 23 (79%) were Class 2 and 6 (21%) were Class 1. In comparison, 10 recurrences were observed in SLN-positive patients and 19 in SLN-negative patients.
- Similar to other studies, DecisionDx-Melanoma demonstrated a strong sensitivity (79%) and negative predictive value (98%), and was an independent and significant prognostic factor by multivariate Cox regression analysis (HR=15.0, p<0.0001).
Podlipnik et al. JEAVD 2019: Consistent performance in multicenter study conducted in Spain.
- This prospective study of 86 patients at 5 dermatology practices demonstrated DecisionDx-Melanoma accurately predicts risk of recurrence both independently and combined with AJCC staging.
- DecisionDx-Melanoma was the only significant predictor of recurrence compared to AJCC staging and age, with a hazard ratio of 18.8%. All recurrences occurred among Class 2 patients.
- When using the test with AJCC staging, the study showed that it can identify high-risk patients in a low-risk AJCC group and low-risk patients in a high-risk AJCC group.
Other Prospective Studies
Greenhaw et al. Dermatol Surg 2018: Negative predictive value of 99% for recurrence shown in early-stage melanoma patients.
- In a prospective cohort of 256 consecutive Stage I and II patients (mean follow up = 23 months), the test accurately identified 10 of 13 metastatic patients as Class 2 (sensitivity=77%), and 211 of 214 patients without a recurrence of melanoma as Class 1 (NPV=99%).
- Overall, Class 2 patients were 22 times more likely to develop metastatic disease, and Kaplan-Meier analysis showed a 5-year metastasis-free survival rate of 93% for Class 1 patients and 69% for Class 2 patients (p < 0.00001).
Renzetti et al. SSO 2017: Combined experience of two tertiary referral centers shows high sensitivity of the test to identify both recurrence and distant metastasis consistent with validation studies.
- In this independent study, 95 patients with Stage I-III disease at two tertiary melanoma centers were tested with DecisionDx-Melanoma (median follow up = 11 months).
- Only 2 (2.4%) Class 1 patients recurred (only one with distant metastasis). Conversely, 13 (24.1%) Class 2 patients recurred, with 10 of these (18.5%) having distant metastasis.
- Class 2 patients had significantly higher rates of recurrence and distant metastasis than Class 1 patients (p=0.02 for both endpoints).
- In this cohort, the sensitivity of DecisionDx-Melanoma to identify those with recurrences as Class 2 was 87% and 91% for distant metastasis.