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DecisionDx®-Melanoma Integrated Test Result Now Includes i31-GEP for Risk of Recurrence
i31-GEP for Risk of Recurrence algorithm integrates DecisionDx-Melanoma score with clinicopathologic factors to provide patient-specific five-year outcomes
About this update from Castle Biosciences, Inc.
[{"type":"text","content":"\ni31-GEP for Risk of Recurrence algorithm integrates DecisionDx-Melanoma score with clinicopathologic factors to provide patient-specific five-year outcomes\n\n FRIENDSWOOD, Texas--(BUSINESS WIRE)--\nCastle Biosciences, Inc. (Nasdaq: CSTL), a company applying innovative diagnostics to inform disease management decisions and improve patient outcomes, today announced that the DecisionDx®-Melanoma integrated test result (ITR) now includes i31-GEP for Risk of Recurrence (i31-ROR). Designed to improve the precision of treatment plans for better patient care, the i31-ROR predicts patient-specific five-year outcomes for melanoma-specific survival (MSS), distant metastasis-free survival (DMFS) and recurrence-free survival (RFS).\n\nDecisionDx-Melanoma is a gene expression profile (GEP) test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as risk of sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 5,700 patient samples.\n\nEarlier this year, Castle launched the ITR for DecisionDx-Melanoma, which included i31-GEP Sentinel Lymph Node Biopsy (i31-SLNB). i31-SLNB is an independently validated algorithm that integrates clinicopathologic features with the 31-GEP score. i31-SLNB is designed to provide a more precise and personalized prediction of sentinel lymph node (SLN) positivity to guide discussions and recommendations, within current risk-based guidelines, for the SLN biopsy (SLNB) surgical procedure.\n\nCastle has now completed independent validation of a new, separate algorithm, i31-ROR, that integrates DecisionDx-Melanoma’s 31-GEP score with the specific Breslow thickness, mitotic rate, SLN status, ulceration status and location (head and neck, extremities, trunk) of the individual patient’s tumor. The additional endpoints of RFS and DMFS, which are not currently provided by the American Joint Committee on Cancer Eighth Edition (AJCC8) staging system, are anticipated to be helpful when determining appropriate treatment pathways for each patient’s disease. The new upgraded ITR now provides both this new i31-ROR result as well as the i31-SLNB, in addition to the traditional class designation obtained with DecisionDx-Melanoma.\n\n“Clinicians and patients look to our tests to provide clinically act...