Therapy Areas: Oncology
Castle Biosciences' DecisionDx-Melanoma Test Identifies High-Risk Melanoma Patients Among Those Traditionally Staged as Low Risk in Newly Published Study
9 January 2019 - - A new publication demonstrating that the DecisionDx-Melanoma gene expression profile test can identify high-risk patients who are likely to recur or die from melanoma within groups of patients often considered low risk based on traditional staging metrics, US-based skin cancer diagnostics company Castle Biosciences, Inc. said.

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