MyPath Melanoma has been well studied over the past nine years in various independent and company-sponsored studies. This publication re-analyzes data from multiple previous performance studies of MyPath Melanoma using a rigorous, standardized method for statistical analysis across studies. Goldberg et al. use a mathematical bootstrapping technique to correct for small, imbalanced, and inconsistent cohort sizes across studies allowing for direct comparison between all studies. The resulting analysis not only found consistently high sensitivity, specificity, positive predictive value, and negative predictive value, but also found no statistically significant difference in performance across both independent and company-sponsored studies.

DecisionDx-SCC identifies patients at the highest risk of nodal/distant metastasis who may derive the greatest benefit from ART, as well as patients who may have clinical indications for ART but are at low risk of metastasis. Compared with current guidelines, 40-GEP could provide greater specificity concerning the benefit of ART in individual patients.

Determine clinical impact of GEP results on the increase/decrease of surgical excision margins and follow-up frequency.

Use of TissueCypher resulted in clinical “upstaging” occurred in 5 of 46 cases, leading to treatment that otherwise might not be pursued.

Two gene expression profile (GEP) tests, the CP-GEP and the 31-GEP, have been developed to identify patients at low risk of SLN positivity who may consider avoiding SLNB. We analyzed the accuracy of the CP-GEP and 31-GEP in identifying patients with <5% risk of SLN positivity across the five validation studies of the CP-GEP and four validation studies of the 31-GEP in T1-T2 tumors.

The management of patient with melanocytic lesions is dependent on the diagnosis with guidelines defining treatment protocols for benign nevi and malignant melanomas. Even though diagnostic discordance and diagnostic ambiguity have been previously established, the real-world impact on patient management is not well understood.Using an exhaustive review process by multiple dermatopathologists and a simulated patient treatment model, this study reveals that diagnostic discordance and ambiguity may be more common that previously reported and identifies significant variation in patient treatment in these lesions.

Diagnostic GEP tests help guide clinical decision-making in a variety of diagnostically ambiguous or clinicopathologically discordant scenarios.

The high accuracy and clinical utility of the 23-GEP test demonstrated across multiple prior studies are applicable to the Medicare-eligible population.

This study shares three-year outcomes data from Castle’s prospective, multicenter study of patients with melanoma who were being considered for an SLNB (n=322). In the study, at three years, all patients with a low-risk DecisionDx-Melanoma test result were recurrence free (recurrence free survival of 100%). The performance data shared in this presentation, in conjunction with previous validation and performance studies, show DecisionDx-Melanoma as an accurate and precise clinical tool that can identify patients who may safely forego SLNB, reducing the number of unnecessary SLNBs performed (by ~25% in this study alone) and the associated costs and risks of complications that accompany them.

ART guidance is not determined by the presence of specific clinicopathologic factors, with treated and untreated patients sharing the same risk factor profiles. cSCC risk determination based on NCCN recommendations for clinical factor assessment results in inconsistent use of ART. Including tumor biology-based prognostic information from the 40-GEP refines risk and identifies patients who are most appropriate and likely to benefit from ART, and those that can consider deferring ART.

The 40-GEP test demonstrates accurate, independent, clinically actionable stratification of metastatic risk and improves predictive accuracy when integrated into risk classification systems. The improved accuracy of risk assessment when including tumor biology via the 40-GEP test ensures more risk-aligned, personalized patient management decisions.

Demonstrate that the 31-GEP offers significant prognostic value in addition to SLN status to help identify patients at the highest risk of tumor recurrence.