Clinical Utility Studies

DecisionDx-Melanoma Clinical Utility Studies

Current national melanoma guidelines indicate that management should be tailored to an individual patient’s risk of recurrence, as this is the most important factor to consider in planning follow up and surveillance.

Given the strong and independent prognostic value of the test, patients with Class 1 tumors can be managed with a less intensive follow-up and surveillance program in accordance with current practice guidelines, allowing for resources to be focused appropriately. Given that Class 2 patients have a higher metastatic risk, it is expected that these patients would be managed with a high-intensity program to enable earlier identification of metastases.

As shown by four recent studies, earlier detection of metastatic disease is important because contemporary melanoma therapies such as immunomodulators are more effective when disease burden is low (Ribas 2016; Menzies 2014; Kaufman 2015; Nishino 2014).

Four peer-reviewed clinical impact studies have shown that the DecisionDx-Melanoma test impacts patient management decisions for
1 of every 2 patients tested. 

Multicenter study with 156 prospectively tested patients

53% change in management

In a multi-center study that evaluated changes in the intensity of management (frequency and type of follow-up and imaging, etc.) for patients receiving the DecisionDx-Melanoma test, 94% had documented post-test changes that were concordant with test-indicated risk (p<0.0001), with decreased intensity for patients with a Class 1 result and increased intensity for Class 2 patients.

Berger et al. CMRO 2016: A clinical utility study with retrospective chart review in a population of consecutive and prospectively clinically tested population from 6 centers.
Prospective multi-center study with 247 patients

49% change in management

This study evaluated management changes in a prospectively enrolled, multi-center cohort of patients, and found that intensity of care was reduced for Class 1 patients, most often impacting the number of office visits and referrals, while Class 2 patients had increased surveillance primarily associated with type and frequency of imaging.

Dillon et al. SKIN 2018: A prospective study documenting physician management changes at 15 dermatologic and surgical centers after receipt of the test result.
Intended decision study with 169 physicians

47% change in management

In this study, physicians were provided with several clinical scenarios and asked how their management would change based on inclusion of the DecisionDx-Melanoma test result; the study found that nearly half of the physicians changed management, and that changes were aligned with predicted risk and national melanoma guidelines.

Farberg et al. J Drugs Dermatol 2017: A physician intent study documenting changes with or without DecisionDx-Melanoma.
Independent, single-center study with 91 patients

52% of decision impact from test class

In an independent single-center study with 91 patients managed at Oregon Health & Science University, patients with a Class 1 test result were more likely to be followed by dermatology alone, while Class 2 patients were followed by surgery in combination with dermatology, medical oncology, and/or recommendations for an adjuvant trial.

Schuitevoerder et al. J Drugs Dermatol 2018: Experience using DecisionDx-Melanoma to guide multidisciplinary management at an academic medical center using a decision tree model.

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).


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