Landmark Study Shows Combination of Castle Biosciences' DecisionDx®-UM and PRAME Outperforms Gene Mutation Analysis in Predicting Survival Outcomes in Uveal Melanoma
1. CSTL's latest study improves UM risk prediction using DecisionDx-UM and PRAME.
2. The combination test outperforms NGS-based mutation analysis for metastatic risk.
3. UM testing widely adopted, guiding patient treatment decisions effectively.
4. DecisionDx-UM test backed by extensive research with significant patient data.
5. COOG plans to expand uveal melanoma clinical trials with improved biomarkers.
Positive study results enhance CSTL's value proposition in oncology diagnostics, reminiscent of past innovations leading to stock price increases, such as Exact Sciences after Cologuard's success.
How important is it?
The study's implications for improved treatment decisions and expanded trials can significantly enhance CSTL’s market presence, leading to increased investor confidence.
Why Long Term?
Strengthened market position and ongoing adoption of tests suggest sustained revenue growth over time, similar to how Illumina's advancements have affected its share price.
Castle Biosciences (Nasdaq: CSTL) Unveils New Insights on Uveal Melanoma Prognosis
FRIENDSWOOD, Texas, Dec. 17, 2025 (GLOBE NEWSWIRE) -- Castle Biosciences, Inc. (Nasdaq: CSTL), renowned for its innovative health solutions, has released ground-breaking data from the largest prospective multicenter study to date. The study compares next-generation sequencing (NGS)-based gene mutation analysis with the combination of the DecisionDx-UM test and Preferentially Expressed Antigen in Melanoma (PRAME) gene expression, specifically for predicting outcomes in uveal melanoma (UM).
Study Overview and Results
This pivotal study, titled “Early Genetic Evolution of Driver Mutations in Uveal Melanoma,” was conducted by the Collaborative Ocular Oncology Group (COOG) and published in Nature Communications. Dr. J. William Harbour, a leading ocular oncologist at UT Southwestern Medical Center, commented on the study's findings, stating, “The COOG2 study validated that combining DecisionDx-UM test results and PRAME gene expression data provides more precise metastatic risk prediction for patients with UM than either test used independently.”
The research showcased that the combination of DecisionDx-UM and PRAME significantly enhances predictions of metastasis-free survival (MFS) and overall survival (OS) over traditional NGS-based mutation analysis. The study evaluated 1,140 primary UM tumors, including 131 early-stage tumors, examining seven clusters of recurrent genetic mutations.
Key Findings and Implications
Enhanced Predictive Capability: The DecisionDx-UM + PRAME combination provided superior predictions of both MFS and OS when compared to NGS-based single gene mutation analysis.
Gene Mutation Analysis: While BAP1, SF3B1, and EIF1AX gene mutations individually indicated varying metastatic risks, their predictive value diminished when considered alongside DecisionDx-UM + PRAME in multivariate analyses.
Comprehensive Risk Stratification: The study's authors attributed the enhanced performance of the DecisionDx-UM + PRAME combination to its ability to measure gene activity from both tumor cells and surrounding immune cells, offering a more holistic view of the tumor microenvironment.
About Uveal Melanoma
Uveal melanoma is a rare yet highly aggressive eye cancer characterized by a significant likelihood of metastasis. Early detection is particularly challenging due to the tumors' tendency to spread while still small, often making them indistinguishable from benign lesions.
Castle Biosciences’ Commitment to Innovation
Castle Biosciences currently provides three major tests for uveal melanoma: DecisionDx-UM, DecisionDx®-PRAME, and DecisionDx®-UMSeq. These tests are designed to deliver the most comprehensive molecular insights available, aiding in precise risk assessment and informed treatment planning.
About the Collaborative Ocular Oncology Group (COOG)
The Collaborative Ocular Oncology Group is recognized as North America's largest working group of expert ocular and medical oncologists specializing in intraocular cancers, particularly uveal melanoma. It encompasses over 25 leading oncology centers and has been continuously funded by the National Cancer Institute for over a decade, planning substantial expansions into clinical trials for uveal melanoma.
About Castle Biosciences
Castle Biosciences (Nasdaq: CSTL) is at the forefront of diagnostic innovation, focusing on improving patient care through advanced, personalized testing solutions. Their commitment to rigorous scientific research enables them to enhance disease management and patient outcomes, particularly in dermatologic and gastroenterological diseases. Interested parties can find more information at www.CastleBiosciences.com.