Study shows a 25% reduction in unnecessary sentinel lymph node biopsy (SLNB) procedures performed when patient’s DecisionDx-Melanoma test results were integrated into clinical decision-making
Among patients electing to have an SLNB, no positive nodes were identified among those with low-risk DecisionDx-Melanoma test results (i.e., predicted sentinel lymph node (SLN) positivity risk of less than 5%), supporting use of the tests’ results to safely inform decisions to forego the procedure
FRIENDSWOOD, Texas--(BUSINESS WIRE)-- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced the latest data from its prospective, multicenter DECIDE study exploring the impact of integrating DecisionDx-Melanoma test results into SLNB decision-making for patients recently diagnosed with melanoma. The updated findings demonstrate the power of the test’s results to accurately identify patients with a low risk of metastasis who can safely forgo SLNB, thereby reducing unnecessary SLNB procedures and the associated costs and risks of complications that accompany them. The data was presented in a poster and oral presentation at The European Congress on Dermato-Oncology (Dermato-Onco2024) recently held in Vienna, Austria.
“We continue to share data from our DECIDE study highlighting the performance of the DecisionDx-Melanoma test in providing precise predictions of SLN positivity, earlier this year at SSO 2024 and now at Dermato-Onco2024, with close to 50% more patients in the study cohort,” said J. Michael Guenther, M.D., surgeon at St. Elizabeth Physicians in Edgewood, Kentucky.1 “As supported by the study data, clinicians can have confidence in decisions made with their patients when discussing a possible SLNB procedure when DecisionDx-Melanoma test results are a part of the conversation.”
Details regarding Castle’s oral presentation at Dermato-Onco2024 are included below:
DecisionDx-Melanoma
- Title: Clinical use of the i31-GEP for SLNB for T1-T2a cutaneous melanoma significantly and safely reduces unnecessary procedures
- Presenting Author: J. Michael Guenther, M.D.
Study highlights
SLNB is an invasive surgical procedure used at the time of diagnosis to determine whether melanoma has spread to nearby lymph nodes. The procedure returns a surgical result that is negative for metastasis in approximately 88% of patients, illuminating the need for additional prognostic information to inform SLNB decisions. The DecisionDx-Melanoma test addresses this need by integrating a patient’s tumor biology with their personal clinicopathologic factors to provide their individual risk of SLN positivity.
Current National Comprehensive Cancer Network (NCCN) guidelines suggest foregoing SLNB when the likelihood of finding a positive SLN is less than 5%, considering SLNB when the risk is between 5-10% and offering the surgery when the likelihood of positivity is above 10%. As such, decision-making for patients whose staging-based-risk falls within or around the 5-10% threshold (i.e., patients with T1a tumors with high-risk features, T1b and T2a tumors) can be the most challenging. The data shared at Dermato-Onco2024 included 471 patients with these tumor stages whose decision to pursue or forgo SLNB surgery was informed by DecisionDx-Melanoma test results.
The study showed that integrating DecisionDx-Melanoma test results into SLNB decisions resulted in 25% fewer SLNBs performed compared to a matched patient cohort (p