New Prospective, Multicenter Study Presented at SMR Demonstrates Castle Biosciences’ DecisionDx®-Melanoma Test Provides Significant Risk Prediction for Patients with Cutaneous Melanoma, Adding Value to Current Stage-Based Treatment Pathway Decisions

On October 9, 2024 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported that it will present new data related to its DecisionDx-Melanoma and DecisionDx-UM tests for patients with cutaneous melanoma (CM) and uveal melanoma (UM), respectively, at the 21st International Congress of the Society for Melanoma Research (SMR), taking place Oct. 10-13, 2024, in New Orleans (Press release, Castle Biosciences, OCT 9, 2024, View Source [SID1234647126]).

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"In large prospective and retrospective studies, our DecisionDx-Melanoma test has been shown to provide clinical value above and beyond current staging paradigms and other tests currently available for patients with cutaneous melanoma," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "Clinical use studies have shown that clinicians act upon these results to improve risk-aligned treatment pathway decisions which are associated with improved outcomes."

Details regarding Castle’s posters at SMR are included below. Posters will be available for viewing starting the evening of Thursday, Oct. 10, through the evening of Saturday, Oct. 12.

DecisionDx-Melanoma

Poster title: In a prospective, multicenter study, the 31-GEP identified patients at increased risk of tumor recurrence and added significant prognostic value to AJCC staging
Poster #: 40
Summary: This study included 876 patients with Stage I-III CM from multiple centers who received DecisionDx-Melanoma testing as part of their clinical care. The data show DecisionDx-Melanoma stratified patients by their risk of recurrence and was a significant predictor of recurrence; patients with Class 1A (lowest risk) test results had significantly higher three-year recurrence-free survival than those with a Class 1B/2A (increased risk) or Class 2B (highest risk) test result (p<0.001). Importantly, the test added significant predictive value to American Joint Committee on Cancer (AJCC) staging, considered the standard of care in melanoma management. These findings provide evidence that use of the test with melanoma patients enables better risk-aligned care decisions, which have been shown to lead to improved patient outcomes.1,2
DecisionDx-UM

Poster title: Confirmation of PRAME status as a risk modifier of 15-gene expression profile class in a large real-world population-based cohort of uveal melanoma patients
Poster #: 134
About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile risk stratification test. It is designed to inform two clinical questions in the management of cutaneous melanoma: a patient’s individual risk of sentinel lymph node positivity and a patient’s personal risk of melanoma recurrence and/or metastasis. By integrating tumor biology with clinical and pathologic factors using a validated proprietary algorithm, DecisionDx-Melanoma is designed to provide a comprehensive and clinically actionable result to guide risk-aligned patient care. DecisionDx-Melanoma has been shown to be associated with improved patient survival and has been studied in more than 10,000 patient samples. DecisionDx-Melanoma’s clinical value is supported by more than 50 peer-reviewed and published studies, providing confidence in disease management plans that incorporate the test’s results. Through June 30, 2024, DecisionDx-Melanoma has been ordered more than 173,000 times for patients diagnosed with cutaneous melanoma. Learn more at www.CastleBiosciences.com.

About DecisionDx-UM

DecisionDx-UM is Castle Biosciences’ 15-gene expression profile (GEP) test that uses an individual patient’s tumor biology to predict individual risk of metastasis in patients with uveal melanoma (UM). DecisionDx-UM is the standard of care in the management of newly diagnosed UM 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 UM 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 currently the only prognostic test for UM 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 UM in the United States receive the DecisionDx-UM test as part of their diagnostic workup. Learn more at www.CastleBiosciences.com.