NOW AVAILABLE: New Integrated Test Result (i31-ROR) for Precise and Personalized Risk of Recurrence Prediction. LEARN MORE
Using Tumor Biology to Provide Information on Risk of Recurrence and Metastasis
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).
Informs Two Key Clinical Management Decisions
Intensity of Follow-Up, Surveillance Imaging, and Referral to Surgical/Medical Oncology
Likelihood of SLNB Positivity Among Eligible Patients with T1-T4 Melanoma
Now Integrating 31-GEP with Clinicopathologic Factors
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
DecisionDx-Melanoma Is Supported by a Robust Body of Evidence
Extensively studied in
6,000+ Patients & 30+ Publications
Well-studied, with over 6,000 Stage I-III cutaneous melanoma patients included in clinical studies and over 30 peer-reviewed scientific publications.
The risk of recurrence to guide management decisions has been clinically validated in 4 long-term multicenter studies showing consistent results.
To provide the likelihood of sentinel lymph node (SLN) positivity, the newly validated i31-SLN algorithm integrates the DecisionDx-Melanoma test score with clinicopathologic factors designed to provide a more precise and personalized risk prediction for patient management guidance.
Accurate prediction of recurrence and metastatic risk demonstrated in
2 Published Systematic Reviews with Meta-Analyses
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
Likelihood of SLN positivity Using i31-SLNB Algorithm that Integrates DecisionDx-Melanoma Test Score with Clinicopathologic Factors
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 with a
99% Technical Success Rate
Strong reproducibility and technical reliability, achieving over 99% technical success rate across more than 53,600 clinical samples.
Demonstrated impact on clinical management decisions for
1 in 2 Patients
7 multicenter and single-center studies showing that DecisionDx-Melanoma use impacts clinical management decisions for 1 of every 2 patients tested.