Castle Biosciences Announces Presentation of Prospective, Multicenter Study Demonstrating Significant Impact of DecisionDx-UM on Treatment Plan Recommendations for Patients with Uveal Melanoma
Data presented at
The CLEAR II study (Clinical Application of DecisionDx-UM Gene Expression Assay Results) was designed to prospectively evaluate metastatic surveillance regimens for patients with uveal melanoma who were tested with the DecisionDx-UM gene expression profile (GEP) test as part of their diagnostic work-up.
“Treatment planning in uveal melanoma is critical since 30% of patients who are diagnosed with uveal melanoma will experience life-threatening metastasis within five years despite successful control of the primary tumor,” commented study co-author and presenter
138 patients from eight centers were enrolled between
March 2018and February 2019.
- 93 patients (67%) had a low-risk Class 1 test result; 45 patients (33%) had a high-risk Class 2 test result.
- Results showed that patients with a Class 2 DecisionDx-UM result were significantly more often followed by medical oncology for surveillance compared to ocular oncology or primary care physicians (p=0.002).
- 95% (42 of 44) of the Class 2 patients who received a referral were referred to medical oncology.
- Patients with a Class 2 result were significantly more likely to receive recommendations for frequent (three or four times a year) abdominal imaging, chest imaging, and liver function testing compared to Class 1 patients (p<0.0001).
- These findings show that treatment plan recommendations are aligned with metastatic risk and consistent with results from previously published studies documenting the impact of DecisionDx-UM on patient management.
DecisionDx-UM is a GEP test that uses an individual patient’s tumor biology to predict individual risk of metastasis. DecisionDx-UM is the standard of care in the management of uveal melanoma in the majority of ocular oncology practices. Since 2009, the American Joint Committee on Cancer (AJCC; v7 and v8) has included GEP testing for the identification of Class 1 and 2 as a prognostic factor recommended for clinical care. In 2018, the National Comprehensive Cancer Network (NCCN) published guidelines on uveal melanoma that include the DecisionDx-UM test results of Class 1A, Class 1B and Class 2B as prognostic factors to guide clinical care. DecisionDx-UM is the only prognostic test for uveal melanoma that has been validated in prospective, multi-center studies. In addition, the DecisionDx-UM test result has been shown to be a superior predictor of metastasis compared to chromosome 3 status, mutational status, AJCC stage, and cell type, as demonstrated in multiple studies.
It is estimated that nearly 8 in 10 patients diagnosed with uveal melanoma in the U.S. receive the DecisionDx-UM test as part of their diagnostic workup. More information about the test and disease can be found at www.MyUvealMelanoma.com.
DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq are trademarks of
Derek Maetzold, President and CEO