Results from this multicenter study of 690 patients demonstrated that the DecisionDx-Melanoma test is an independent predictor of risk for recurrence, metastasis and melanoma-specific death.
The study was published in the January 2019 issue of the Journal of the American Academy of Dermatology.
Patients from three previously published DecisionDx-Melanoma validation studies were combined to enable analysis of test performance in the following three clinically important subgroups that are traditionally considered low risk based on current national melanoma guidelines: (1) patients who had a negative sentinel lymph node biopsy; (2) those with American Joint Committee on Cancer Stage I-IIA melanoma; and (3) those with thin (≤1 mm) tumors.
The DecisionDx-Melanoma test was performed to determine molecular class for each patient, with a Class 1A result indicating the lowest 5-year risk of metastasis and a Class 2B result indicating the highest risk.
Study endpoints included recurrence-free survival (RFS; time to local, regional or distant recurrence), distant metastasis-free survival (DMFS; time to any distant metastasis) and melanoma-specific survival (MSS; time to documented death from melanoma).
In this population of 690 unique Stage I-III patients with at least five years of follow-up or a metastatic event, median age was 59 years and median Breslow thickness was 1.3 mm.
Seventy percent of patients had Stage I or II melanoma.
In the pooled cohort, patients with Class 1A results had significantly higher RFS, DMFS and MSS rates compared to Class 2B (p
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