In Novel Cohort, New Data Confirms DecisionDx®-SCC Provides Significant, Independent and Clinically Actionable Risk-Stratification of Patients, Including in Various High-Risk Subgroups


Largest study of gene expression profile testing in patients with high-risk cutaneous squamous cell carcinoma (SCC) supports test’s ability to provide clinically actionable risk stratification to guide treatment decisions for patients diagnosed with this impactful skin cancer

FRIENDSWOOD, Texas--(BUSINESS WIRE)-- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced the publication of a new multi-center performance study of its DecisionDx-SCC risk stratification test. The study, published in Dermatology and Therapy and available here, analyzed the independent performance of DecisionDx-SCC from risk factors and traditional staging systems (i.e., Brigham and Women’s Hospital (BWH) and American Joint Committee on Cancer Staging Manual 8th Edition (AJCC8) staging), and demonstrated significantly improved predictive accuracy when the test’s results were integrated with the staging systems and National Comprehensive Cancer Network® (NCCN) guidelines to guide risk-appropriate treatment pathway decisions that can improve patient outcomes.

“Data-driven risk assessment is the foundation of sound clinical decision-making,” said Ashley Wysong, M.D., M.S., lead study author, professor, distinguished chair of dermatology and founding chair of the department of dermatology at the University of Nebraska Medical Center. “Incorporating DecisionDx-SCC test results into the management of high-risk SCC can help ensure patients receive the best care possible by incorporating their biological risk of metastasis into the treatment plan. Use of the test in clinical practice can help with optimization of healthcare resources by reducing both overtreatment of patients with a low biological risk of metastasis and undertreatment of patients with aggressive tumor biology.”

The DecisionDx-SCC test was developed and validated to improve the accuracy of metastatic risk prediction for patients with high-risk SCC, classifying patients as low (Class 1), higher (Class 2A) or highest risk (Class 2B) of regional or distant metastasis within three years based on the gene expression profile of their tumor. The data in this study support use of the test’s results in the clinical management of high-risk SCCs as they can provide impactful risk-stratification to guide risk-appropriate treatment pathway decisions, such as the use of nodal assessment (i.e., imaging) and adjuvant radiation therapy (ART).

The goal of this study was to present an independent validation of the DecisionDx-SCC test in a novel performance cohort (n=534) and then merge it with the test’s initial independent validation cohort (n=420) to evaluate the performance of the test in providing independent prognostic value to risk classification systems, individual clinicopathologic risk factors and clinically relevant patient populations.1-2 In the study, DecisionDx-SCC demonstrated statistically significant risk-stratification of patients with high-risk SCC (p6mm) (p

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