- Castle Biosciences (CSTL, Financial) confirms the validity of the DecisionDx-UM test for predicting metastatic risk in uveal melanoma.
- Integration of the PRAME biomarker enhances risk prediction capabilities for this aggressive eye cancer.
- Study involved a substantial real-world cohort of 1,297 patients, validated by NCI SEER data.
Castle Biosciences (CSTL) presented compelling new data at the ARVO 2025 Annual Meeting, confirming the long-term performance of its DecisionDx-UM test used in the management of uveal melanoma (UM). The study analyzed a substantial cohort of 1,297 patients with UM, reinforcing findings from the COOG2.1 study. It demonstrates that incorporating PRAME gene expression data alongside DecisionDx-UM test results provides enhanced insights into metastatic risk stratification, thereby aiding in more personalized treatment strategies for patients.
Uveal melanoma, a rare yet aggressive form of eye cancer, affects approximately 2,500 new individuals annually in the United States, with a significant metastatic potential of about 50%. Given these statistics, the need for precise risk stratification is critical for effective management. The integration of PRAME biomarker data allows for a finer subdivision of DecisionDx-UM Class 1 and Class 2 tumors, based on whether the PRAME status is positive or negative. This differentiation aids oncologists in tailoring surveillance and treatment plans specific to individual patient risk.
The study's real-world validation, supported by the National Cancer Institute's Surveillance, Epidemiology, and End Results (NCI SEER) Program, solidifies its findings within clinical settings, further reinforcing the test's applicability beyond controlled research environments. This development is pivotal for Castle Biosciences as it seeks broader adoption of its diagnostic technologies among clinicians and healthcare payers, ultimately enhancing treatment outcomes for uveal melanoma patients.
