On October 20, 2024 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported new data supporting the clinical utility of its DecisionDx-Melanoma and DecisionDx-SCC tests in guiding risk-aligned treatment decisions, including SLNB for patients with melanoma and surveillance imaging for those with SCC (Press release, Castle Biosciences, OCT 20, 2024, View Source [SID1234647276]). The data were shared in two video abstracts at the 2024 American Society for Dermatologic Surgery (ASDS) Annual Meeting, held Oct. 17-20, 2024, in Orlando, Florida.

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"While staging is an important part of skin cancer risk assessment, well-validated molecular tests like DecisionDx-Melanoma and DecisionDx-SCC are designed to look deeper into the biology of a patient’s tumor to provide additional insight into its likely behavior," said Etan Marks, D.O., board-certified pathologist, laboratory director and primary investigator at Advanced Dermatology and Cosmetic Surgery in Delray Beach, Florida. "As demonstrated in the studies at ASDS, these insights can enhance clinical decision-making and arm clinicians with more precise risk information to help route patients to the most appropriate modality aligned to their risk of metastasis and survival."

Details regarding Castle’s video abstracts presented at ASDS are included below:

DecisionDx-Melanoma

Title: The i31-GEP identifies patients with T1 cutaneous melanoma who can safely avoid sentinel lymph node biopsy: Results from a prospective, multicenter study
Lead Author: Etan Marks, D.O., Advanced Dermatology and Cosmetic Surgery, Delray Beach, Florida
Key take-aways:
National Comprehensive Cancer Network (NCCN) guidelines regarding SLNB are most ambiguous for patients with T1a tumors with high-risk features and T1b tumors, for whom SLNB may be considered due to an increased risk of metastasis. Data from this ongoing prospective, multicenter study (CONNECTION) confirm that DecisionDx-Melanoma can identify patients with T1 tumors with a low risk of sentinel lymph node positivity who can safely forgo SLNB (negative predictive value of 98.4%), while maintaining very high survival rates in low-risk patients who did not have an SLNB (three-year recurrence free survival rate of 99.5%).1 Additionally, the data indicate that using DecisionDx-Melanoma test results to guide SLNB decisions in patients with T1 tumors could have reduced the number of unnecessary biopsies by up to 64%, as well as procedure-related complications and health care costs.
View video abstract here.
DecisionDx-SCC

Title: The 40-gene expression profile (40-GEP) test enhances risk-aligned guidance for surveillance imaging in high-risk cutaneous squamous cell carcinoma (cSCC)
Lead Author: Emily S. Ruiz, M.D., MPH, Brigham and Women’s Hospital and Harvard Medical School, Boston
Key take-aways:
Radiologic surveillance imaging in patients with high-risk SCC can identify disease recurrence earlier, which may improve patient outcomes. This study evaluated the utility of the DecisionDx-SCC test in guiding these decisions in patients with higher stage disease (i.e., patients with BWH T2b SCC tumors), whom studies have shown are at a higher likelihood of nodal or distant metastasis relative to lower-staged patients. In the study, approximately 42% of the patients with T2b tumors who received radiologic surveillance imaging received a Class 1 (low risk) test result and had a metastasis rate of 5.9%, indicating that clinicians could have safely deferred surveillance imaging for these Class 1 patients due to the low metastatic rate. For patients who were not imaged, almost 50% received a Class 2A or 2B (higher or highest risk) test result and had an 18.8% metastasis rate, suggesting that these patients may have benefitted from imaging to promote early detection of disease progression and improved outcomes. Overall, these data demonstrate the utility of DecisionDx-SCC to help improve selection of BWH T2b patients for radiologic surveillance imaging based on their biological risk of metastasis, as provided by the test.
View video abstract here.
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-SCC

DecisionDx-SCC is a 40-gene expression profile test that uses an individual patient’s tumor biology to stratify risk of metastasis in patients with cutaneous squamous cell carcinoma who have one or more NCCN high-risk factors. The test result, in which patients are stratified into a Class 1 (low), Class 2A (higher) or Class 2B (highest) risk category, predicts individual metastatic risk to inform risk-appropriate management and guide decision-making regarding the use of adjuvant radiation therapy. Peer-reviewed publications have demonstrated that DecisionDx-SCC is an independent predictor of metastatic risk and that the test can significantly improve risk-stratification when used with traditional staging systems and clinicopathologic risk factors to guide risk-aligned management and treatment decisions. Learn more at www.CastleBiosciences.com.