Castle Biosciences, a manufacturer of molecular diagnostics for cancer treatments, recently revealed current clinical data on a new test designed to predict metastasis in patients with uveal melanoma.
The information about DecisionDx-UM, the company’s gene expression profile (GEP) test was presented during the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting.
Uveal Melanoma is a rare form of cancer that begins in melanocytes, which are cells that help produce skin, hair and eyes pigmentation. The cancer affects the eye’s pigmented layer that lies beneath the sclera and cornea, and makes up the iris, choroid, and ciliary body.
The study, “A Prospective, Multi-Center Study to Evaluate the Performance and Clinical Utility of a 15-Gene Expression Profile for Uveal Melanoma,” presented findings from the prospective, multi-center Clinical Application of DecisionDx-UM Gene Expression Assay Results (CLEAR) study.
The presentation described how physicians use DecisionDx-UM to design individual treatment plans; and it tracked the clinical management and metastatic outcomes of patients with low-risk Class 1 (37 patients, 53%) or high-risk Class 2 (33 patients, 47%) GEP test results with no evidence of distant metastasis at the time of primary tumor treatment.
According to a recent press release:
- All Class 2 patients were managed with high-intensity surveillance – imaging and/or liver function tests every three to six months.
- 81% of Class 1 participants were managed with low-intensity surveillance – imaging and/or liver function tests at every 12 months.
- A significant difference in management of Class 1 and Class 2 patients had occurred.
- 33% of Class 2 patients were referred to a medical oncologist for surveillance and/or clinical trial enrollment versus 11% of Class 1 patients.
- Two Class 1 patients and 12 Class 2 patients developed metastasis with a median follow-up of 27.3 months
- At three years, metastasis-free survival rates were 100% for Class 1 patients and 63% for Class 2 patients.
Castle Biosciences’ President and Chief Executive Officer, Derek Maetzold said the study demonstrated clinically and statistically significant impact on follow-up treatment consistent with study reports “confirming the robustness of the DecisionDx-UM test.”