Clinical Utility Studies
A single-center study in a surgical oncology setting evaluated 112 consecutively diagnosed patients and demonstrated that management decisions were impacted by the use of DecisionDx-Melanoma. Recommended surveillance duration and number of follow-up clinical visits, blood work and imaging were significantly longer for Class 2 patients compared with Class 1 patients (p<0.001) and were independent of AJCC stage. Clinicians using DecisionDx-Melanoma test results were shown to adjust patient management in a risk-appropriate direction, within recommendations of national guidelines (Hyams 2020).
An additional independent, single-center study in a surgical practice used a retrospective review to assess how DecisionDx-Melanoma altered management for 26 patients with cutaneous melanoma. Changes were observed for approximately 1 in 2 patients, including forgoing SLNB in two Class 1 patients over 65 years of age, and adding PET/CT to eight patients receiving a Class 2 result. Although the sample size is small, this study provides further evidence that DecisionDx-Melanoma is applied in a risk-appropriate manner to delegate resources to patients likely to benefit most (Scott 2020).