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 American Academy of Ophthalmology 2019 Annual Meeting

FRIENDSWOOD, Texas--(BUSINESS WIRE)-- Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions in skin cancers and uveal melanoma, today announced the presentation of a multicenter, prospective study demonstrating that DecisionDx®-UM test results significantly impacted treatment plan recommendations for patients with uveal melanoma. The study was presented at the American Academy of Ophthalmology 2019 Annual Meeting held October 12-15, 2019, in San Francisco.

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 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. “The results from the CLEAR II study demonstrate that the DecisionDx-UM test has a significant impact on treatment planning, helping to ensure that patients receive imaging, follow-up and referrals that are appropriate for their individual risk.”

Study Highlights:

  • 138 patients from eight centers were enrolled between March 2018 and 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

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