Castle Biosciences has announced that data from studies of its DecisionDx-Melanoma test confirm previous studies, indicating that the gene expression profile test is a strong predictor for classifying which Stage I or II non-metastatic cutaneous melanoma will likely recur in patients.
Castle Biosciences has presented clinical data from studies of its DecisionDx-Melanoma test at the summer academy meeting of the American Academy of Dermatology (AAD).
DecisionDx-Melanoma test is designed to predict metastasis by measuring the expression levels of 31 genes in the patient’s tumor.
The new test stratifies patients as class 1 (low risk of metastasis), or class 2 (high risk of metastasis), based on which tumor genes are turned on and off.
The results were presented by Dr Pedram Gerami, associate professor of dermatology, director of melanoma research at the Northwestern Skin Cancer Institute, Northwestern University.
Dr Gerami said that up to one-third of Stage II melanoma patients, and 10% of Stage I patients, are at risk for developing future metastatic disease.
To date, the test has analyzed archived tumor samples from more than 400 Stage I and II melanoma patients in prospectively designed studies.
Castle Biosciences president and CEO Derek Maetzold said, "Insight into a tumor’s genes, in combination with traditional staging methods, gives doctors and patients the ability to individualize follow-up care that matches metastatic risk with treatment planning."
Investigators found that five-year metastasis free survival rates were 98% for class 1 and 37% for class 2 (P<0.0001), according to Kaplan-Meier analysis (accuracy = 85%, sensitivity = 86%).
Cox proportional multivariate analysis found the test to be independent of Breslow, mitosis and ulceration as well as AJCC stage (p<0.01).