On March 26, 2020 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported the publication of a multicenter, prospective study demonstrating that DecisionDx-UM test results significantly impacted treatment plan recommendations for patients with uveal melanoma (UM) (Press release, Castle Biosciences, MAR 26, 2020, View Source [SID1234555881]). The study was published in the peer-reviewed journal Melanoma Management.

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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 current standard of care for uveal melanoma patients. 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.

The multicenter CLEAR II study (Clinical Application of DecisionDx-UM Gene Expression Assay Results II) was designed to prospectively evaluate patterns of physician referral and metastatic surveillance regimens for UM patients who were tested with DecisionDx-UM as part of their diagnostic work up, and to compare management plans between DecisionDx-UM low-risk (Class 1) and DecisionDx-UM high-risk (Class 2) patients.

"The results from the CLEAR II study demonstrate that the DecisionDx-UM test has a significant impact on treatment plan recommendations for patients with uveal melanoma," said first author Amy C. Schefler, M.D., Associate Professor of Clinical Ophthalmology, Weill Cornell Medical College/Houston Methodist Hospital and the University of Texas Health Science Center at Houston, and Retina Consultants of Houston. "DecisionDx-UM stratifies patients, based on tumor biology, into high- and low-risk groups, and this study demonstrates that physicians developed appropriate, risk-aligned treatment plans based on this genomic information."

Study Highlights:

138 patients from nine centers were enrolled in the CLEAR II study.
93 patients (67%) had a low-risk Class 1 test result; and 45 patients (33%) had a high-risk Class 2 test result. This ratio is consistent with clinical experience (in 2019, 68% of all test results were Class 1, and 32% were Class 2 test results).
Medical oncology referral was more common for high-risk Class 2 patients than for low-risk Class 1 patients (p<0.001).
Class 1 patients were less likely to have their metastatic surveillance managed by a medical oncologist compared to Class 2 patients (p<0.001).
Patients with a Class 1 result were significantly less likely to receive recommendations for frequent (three or four times a year) surveillance imaging and liver function testing compared to Class 2 patients (p<0.001).
These findings show that treatment plan recommendations are aligned with metastatic risk and are consistent with results from previously published studies documenting the impact of DecisionDx-UM on patient management.
About DecisionDx-UM

DecisionDx-UM is a 15-gene expression profiling (GEP) test that uses an individual patient’s tumor biology to predict individual risk of metastasis. DecisionDx-UM is considered to be standard of care in the management of uveal melanoma in the majority of ocular oncology practices in the United States. Since 2009, the American Joint Committee on Cancer (AJCC; v7 and v8) Staging Manual for UM has specifically identified the GEP test as a prognostic factor that is recommended for collection as a part of clinical care. Further, the National Comprehensive Cancer Network (NCCN) guidelines for uveal melanoma include the DecisionDx-UM test result as a prognostic method for determining risk of metastasis and recommended differential surveillance regimens based on a Class 1A, 1B, and 2 result. DecisionDx-UM is the only prognostic test for uveal melanoma that has been validated in prospective, multi-center studies, and it has been shown to be a superior predictor of metastasis compared to other prognostic factors, such as chromosome 3 status, mutational status, AJCC stage and cell type.

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.