New Data: DecisionDx®-SCC Outperforms BWH Staging for High-Risk Skin Cancer Treatment

Castle Biosciences, Inc. (Nasdaq: CSTL), a company focused on improving health through innovative diagnostic tests, announced new data showing that its DecisionDx-SCC test offers clinically significant risk stratification for high-risk SCC patients, particularly those with suppressed immune systems. This enhanced stratification can help guide treatment intensification, such as adjuvant radiation therapy (ART). The findings will be presented at the ASTRO 2024 Annual Meeting, taking place from September 29 to October 2 in Washington, D.C.

“The DecisionDx-SCC test has been validated to independently predict the likelihood of metastasis beyond traditional staging and clinicopathologic risk factors, aiding critical treatment decisions for SCC patients,” said Dr. Shlomo A. Koyfman, radiation oncologist at Cleveland Clinic and lead author of the study. “Our data presented at ASTRO highlights the test’s utility for immune-suppressed patients with lower-stage SCC tumors, who may face an increased risk of metastasis due to their immune status. These patients could benefit from intensified surveillance and adjuvant treatments like radiation post-tumor removal to mitigate this risk.”

Presentation Details at ASTRO 2024:

  • Abstract Title: Use of the 40-gene expression profile (40-GEP) test to identify immune-suppressed patients with BWH T1-T2a cutaneous squamous cell carcinoma (cSCC) at higher risk of metastasis: Implications for adjuvant radiation
  • Abstract ID: 1065
  • Lead Authors: Dr. Shlomo A. Koyfman and Karina Brito, Cleveland Clinic
  • Session Type: Quick Pitch
  • Session: QP 12 – Sarcoma 2: Advancing Treatment Frontiers in Cutaneous Malignancies and Sarcoma
  • Date & Time: Tuesday, Oct. 1, 2:30-2:40 p.m. Eastern Time
  • Location: Room 151

Summary: The study analyzed an independent cohort of 954 SCC patients, all with at least one NCCN high-risk factor, who underwent DecisionDx-SCC testing. The cohort included 441 patients with BWH T1 tumors and 336 with BWH T2a tumors, with no residual tumor after Mohs surgery. The DecisionDx-SCC test successfully stratified these patients by metastasis-free survival (MFS), particularly highlighting the increased risk for immune-suppressed patients with T2a tumors. These patients showed significantly worse MFS compared to immune-competent patients, emphasizing the potential need for intensified treatments like adjuvant radiation guided by DecisionDx-SCC results.

The full abstract is available in the ASTRO Annual Meeting Portal and will be published in the International Journal of Radiation Oncology • Biology • Physics (Red Journal).

About DecisionDx-SCC

DecisionDx-SCC is a 40-gene expression profile test that evaluates an individual’s tumor biology to assess the risk of metastasis in patients with cutaneous squamous cell carcinoma who have one or more NCCN high-risk factors. The test classifies patients into risk categories (Class 1, 2A, or 2B) to inform treatment decisions, including the use of adjuvant radiation therapy. Peer-reviewed studies have demonstrated that DecisionDx-SCC independently predicts metastatic risk and enhances risk stratification when combined with traditional staging and clinicopathologic factors.

About Castle Biosciences

Castle Biosciences (Nasdaq: CSTL) is a diagnostics company dedicated to improving health through innovative tests that guide patient care. The company’s portfolio includes tests for skin cancers, Barrett’s esophagus, mental health conditions, and uveal melanoma, with ongoing research in other high-need areas such as atopic dermatitis and psoriasis. Castle Biosciences focuses on transforming disease management by prioritizing the needs of patients, clinicians, employees, and investors.

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