DecisionDx DiffDx-Melanoma Overview

A Highly Accurate and Objective Test for Difficult-to-Diagnose Melanocytic Lesions

DecisionDx^® DiffDx^™-Melanoma is a new gene expression profile test designed to reduce diagnostic uncertainty by providing a highly accurate and objective evaluation. DiffDx-Melanoma adds diagnostic clarity leading to a more confident diagnosis and a clearer treatment path for patients.

A Definitive Diagnosis is Important to Patient Management Decisions

It is estimated that there are over 2 million biopsies of suspected melanoma annually in the U.S. Approximately 85% of these biopsies receive a definitive diagnosis of either benign or malignant by a dermatopathologist using traditional microscopic analyses. However, up to 300,000 lesions cannot be confidently diagnosed with traditional histopathology. These difficult-to-diagnose melanocytic lesions require additional, or ancillary, testing before a definitive diagnosis can be reached. It is important to reduce uncertainty and reach a definitive diagnosis as quickly as possible to inform important patient management decisions regarding primary treatment and follow up.

Designed to Reduce Diagnostic Uncertainty

Leveraging artificial intelligence-based technology, DiffDx-Melanoma provides a high level of accuracy and low technical failure. Validation of the test included a variety of benign and malignant lesions. In the clinical validation study, DiffDx-Melanoma provided a clinically actionable result in greater than 96% of reported cases. When considered along with histology and clinical information, DiffDx-Melanoma provides greater diagnostic certainty and reduces ambiguity for lesions of uncertain malignant potential. The test enhances clinical confidence that patients receive the most appropriate management plan based on a highly accurate objective evaluation.