An independent study of Castle Biosciences’ DecisionDx-Melanoma gene expression profile test, used to identify the risk of metastasis in patients with stage 1 or 2 cutaneous melanoma, verified the accuracy and advantage of the assay, which has been used clinically in more than 7,500 patients.
The study, “Estimation of Prognosis in Invasive Melanoma Using a Gene Expression Profile Test,” was presented at the recent 48th Annual Meeting of the American College of Mohs Surgery in Orlando, Florida, and included analysis of tumor tissue from a total of 257 patients. The test analyzes the expression of 31 genes that have previously been associated with progression of melanoma. It produces a gene expression signature that is used to classify tumors as either high or low risk of metastasis.
“Our independent study results demonstrate a strong Negative Predictive Value of 98.6 percent for any metastatic event and 99.5 percent for melanoma-specific mortality, and are consistent with Castle Biosciences’ sponsored multi-center validation and performance studies for the test,” John A. Zitelli from the Zitelli & Brodland Skin Cancer Center, Pittsburgh, said in a press release. “Based on these study results and previously published data, our center employs an institutional protocol involving regular and intense clinical skin and nodal follow-up exams on high-risk Class 2 patients, and a lower intensity follow-up regimen on low-risk Class 1 patients.”
The DecisionDx-Melanoma test has been validated and evaluated in prospective studies of more than 1,000 melanoma patients, in addition to the independent performance studies.
“Consistent with the results from the first two published clinical validation studies, this independent performance study demonstrates that patients with a DecisionDx-Melanoma Class 2 signature were 22 times more likely to develop metastatic disease than those with a low-risk Class 1 result. Implementing a follow-up management plan aligned with an individual patient’s risk of recurrence is consistent with three other completed clinical utility studies and national guidelines,” said Derek Maetzold, president and CEO of Castle Biosciences.
“In this study, the DecisionDx-Melanoma test accurately identified both high-risk patients who are missed by traditional staging systems, and patients who are at low risk of metastasis with a Class 1 designation,” he added. “These data provide further confirmation that the DecisionDx-Melanoma test is a clinically important tool to identify risk of metastasis and guide follow-up management for early stage patients.”
More information about the DecisionDx-Melanoma gene expression profile test can be found at www.skinmelanoma.com.