Study Published Recently in Ocular Oncology and Pathology
FRIENDSWOOD, Texas--(BUSINESS WIRE)-- Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, today announced the publication of a multicenter, prospective study demonstrating that DecisionDx®-UM test results significantly impacted treatment plan recommendations for patients with uveal melanoma (UM).
The article titled, “Gene expression profiling in uveal melanoma: five-year prospective outcomes and meta-analysis,” was published in the peer-reviewed journal Ocular Oncology and Pathology.
DecisionDx-UM is Castle’s 15-gene expression profiling (GEP) test developed to identify patients at low risk (Class 1) or high risk (Class 2) of metastasis, based on the unique biology of their primary tumor, and is the current standard of care for UM patients. It is estimated that nearly 8 in 10 patients diagnosed with UM in the U.S. receive the DecisionDx-UM test as part of their diagnostic workup. UM patients face up to a 50% risk of metastasis, despite successful control of the primary tumor.
The multicenter CLEAR Registry Study (Clinical Application of DecisionDx-UM Gene Expression Assay Results) was designed to prospectively evaluate management plans and five-year clinical outcomes for UM patients tested with DecisionDx-UM as part of their clinical care. The median follow-up time for patients who did not develop metastasis was 4.9 years, reflecting the longest follow-up reported to date for any prognostic tool for UM.
“The accurate and reliable identification of a patient’s metastatic risk is critical for clinical planning and decision-making,” commented first author, Thomas Aaberg, Jr., M.D., associate clinical professor at Michigan State University Medical School and ocular oncologist with Retina Specialists of Michigan. “As with previously published studies, the results of the CLEAR study demonstrate the high-level of accuracy of DecisionDx-UM for prediction of metastatic risk and further support its use in guiding patient management.”
Study Background and Highlights:
- Eighty-nine patients with DecisionDx-UM results were prospectively enrolled at four centers. Sample size calculations indicated that 29 patients would be sufficient to demonstrate a statistically significant difference in metastatic rates between Class 1 and Class 2 patients, while 47 patients would be sufficient to detect differences in melanoma-specific mortality.
- Physician-recommended management plans were collected, and clinical outcomes tracked every six months.
- Five-year DecisionDx-UM Class 1 and DecisionDx-UM Class 2 metastasis-free survival rates were 90% and 41% (p