DecisionDx-Melanoma is a validated 31-gene expression profile (GEP) test that was developed to identify the risk of recurrence or metastasis including the likelihood of sentinel lymph node positivity for patients with stage I, II, or III melanoma and inform patient management decisions. The DecisionDx-Melanoma test accurately and independently predicts the risk of recurrence and metastasis, classifying patients as Class 1A (lowest risk), 1B/2A (increased risk), or 2B (highest risk).
Using validated algorithms, the DecisionDx-Melanoma Class Score is now integrated with patient clinicopathologic factors to further individualize risk of recurrence (i31-ROR) and sentinel lymph node biopsy positivity prediction (i31-SLNB).
31-GEP Score + Clinpath factors = i31-ROR
31-GEP Score + Clinpath factors = i31-SLNB
Well-studied, with over 9,000 Stage I-III cutaneous melanoma patients included in clinical studies and over 35 peer-reviewed scientific publications.
Two published systematic reviews with meta-analyses showing that DecisionDx-Melanoma achieves the highest, Level 1A evidence, as an independent, significant predictor of recurrence and metastatic risk.
Artificial intelligence neural network algorithm
Developed using a published cohort of 1,398 patients (Vetto 2019) and independently validated in a cohort of 1,674 patients (Cook 2019) and designed to provide a precise and personalized likelihood of SLN positivity.
Strong reproducibility and technical reliability, achieving over 99% technical success rate across more than 53,600 clinical samples.
7 multicenter and single-center studies showing that
DecisionDx-Melanoma use impacts clinical management decisions for 1 of every 2 patients tested.
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