title: Clinical Performance and Management Outcomes with the DecisionDx-UM Gene Expression Profile Test in a Prospective Multicenter Study.
abstract: Uveal melanoma management is challenging due to its metastatic propensity. DecisionDx-UM is a prospectively validated molecular test that interrogates primary tumor biology to provide objective information about metastatic potential that can be used in determining appropriate patient care. To evaluate the continued clinical validity and utility of DecisionDx-UM, beginning March 2010, 70 patients were enrolled in a prospective, multicenter, IRB-approved study to document patient management differences and clinical outcomes associated with low-risk Class 1 and high-risk Class 2 results indicated by DecisionDx-UM testing. Thirty-seven patients in the prospective study were Class 1 and 33 were Class 2. Class 1 patients had 100% 3-year metastasis-free survival compared to 63% for Class 2 (log rank test p = 0.003) with 27.3 median follow-up months in this interim analysis. Class 2 patients received significantly higher-intensity monitoring and more oncology/clinical trial referrals compared to Class 1 patients (Fisher's exact test p = 2.1 × 10(-13) and p = 0.04, resp.). The results of this study provide additional, prospective evidence in an independent cohort of patients that Class 1 and Class 2 patients are managed according to the differential metastatic risk indicated by DecisionDx-UM. The trial is registered with Clinical Application of DecisionDx-UM Gene Expression Assay Results (NCT02376920).
authors.affiliation: Castle Biosciences, Friendswood, TX 77546, USA.
authors.forename: Kristen Meldi
authors.initials: KM
authors.lastname: Plasseraud
authors.affiliation: Castle Biosciences, Friendswood, TX 77546, USA.
authors.forename: Robert W
authors.identifier: 0000-0003-1166-4796
authors.initials: RW
authors.lastname: Cook
authors.affiliation: Retinal Consultants, Sacramento, CA 95819, USA.
authors.forename: Tony
authors.initials: T
authors.lastname: Tsai
authors.affiliation: University of Virginia, Charlottesville, VA 22908, USA.
authors.forename: Yevgeniy
authors.initials: Y
authors.lastname: Shildkrot
authors.affiliation: Castle Biosciences, Friendswood, TX 77546, USA.
authors.forename: Brooke
authors.initials: B
authors.lastname: Middlebrook
authors.affiliation: Castle Biosciences, Friendswood, TX 77546, USA.
authors.forename: Derek
authors.initials: D
authors.lastname: Maetzold
authors.affiliation: Castle Biosciences, Friendswood, TX 77546, USA.
authors.forename: Jeff
authors.initials: J
authors.lastname: Wilkinson
authors.affiliation: Castle Biosciences, Friendswood, TX 77546, USA.
authors.forename: John
authors.initials: J
authors.lastname: Stone
authors.affiliation: Castle Biosciences, Friendswood, TX 77546, USA.
authors.forename: Clare
authors.initials: C
authors.lastname: Johnson
authors.affiliation: Castle Biosciences, Friendswood, TX 77546, USA.
authors.forename: Kristen
authors.initials: K
authors.lastname: Oelschlager
authors.affiliation: Michigan State University Medical School and Retina Specialists of Michigan, Grand Rapids, MI 49546, USA.
authors.forename: Thomas M
authors.initials: TM
authors.lastname: Aaberg