A health economics study using a microsimulation model showed that TissueCypher-guided management is both cost-saving and helps improve patient health outcomes.

The i31-GEP identified patients with < 5% risk of SLN positivity who could safely forego SLNB. Combining the 31-GEP with clinicopathologic features for a precise risk estimate can help guide risk-aligned patient care decisions for SLNB to reduce the number of unnecessary SLNBs and increase the SLNB positivity yield if the procedure is performed.

The 40-GEP identified patients most likely to benefit from ART (Class 2B) and those that can consider deferring treatment (Class 1).

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.

This multicenter clinical experience study evaluated TissueCypher results from 8,080 patients across 505 U.S. clinical sites. TissueCypher provided objective risk stratification across clinically relevant patient groups, including identifying a subset of patients with non-dysplastic Barrett’s esophagus at increased risk of progression.

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.

Assess the ability of the 40-GEP test to significantly improve metastatic risk prediction of NCCN, AJCC8, and BWH staging systems when included.

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.