The sentinel lymph node biopsy (SLNB) procedure is a standard staging surgical procedure with prognostic value that identifies Stage III patients who can potentially benefit from targeted and immunotherapeutic agents in the adjuvant setting.9-10 However, the SLNB is negative up to 80% of the time and associated with surgical complications and high cost.9-11 CP-GEP was optimized to identify patients who are likely negative for sentinel lymph node and who could, thus, safely forgo the SLNB procedure, which would reduce potential surgical complications and healthcare costs.12-13 CP-GEP has been clinically validated in over 4,700 patients to predict nodal metastasis; validation has come from independent studies across different types of clinical institutions in the United States and Europe.1,4-8,12-18
Multiple studies have reported on long-term outcomes for 5-year recurrence-free survival (RFS), distant metastasis-free survival (DMFS), and overall survival (OS)/melanoma-specific survival (MSS) rates in CP-GEP low-risk and high-risk patients.5-8 These studies validated the CP-GEP's ability to stratify risk of cutaneous melanoma patients across stages I through III, including the SLNB-negative, early stage I/II patient population. Around 40% of melanoma patients who relapse or die initially have a diagnosis of early stage I/II melanoma.7 A patient’s risk of recurrence is central to management choices, and accurate identification of a patient’s individual risk ensures the application of the most appropriate clinical management plan, with more aggressive strategies recommended for patients who are at a higher risk.7,10