DecisionDx® DiffDx-Melanoma


Introducing DecisionDx® DiffDx-Melanoma

A Highly Accurate and Objective Genomic Test

DiffDx-Melanoma is a new gene expression profile test to aid dermatopathologists in characterizing difficult-to-diagnose melanocytic lesions by providing a highly accurate, objective result. DiffDx-Melanoma can add to diagnostic clarity and provide confidence to dermatopathologists while helping dermatologists deliver more informed patient management plans.

Difficult-to-Diagnose Melanocytic Lesions Are a Problem

It is estimated that there are over 2 million biopsies of suspected melanoma annually in the U.S., leading to:


Over 130,000 invasive malignant melanomas


Nearly 96,000 diagnoses of melanoma in situ


Up to 300,000 lesions that cannot be confidently diagnosed with a routine H&E

And the Impact of Ambiguity is Significant

Patient Health

Undertreatment of melanoma can lead to tumor spread and greatly increases the risk of melanoma-specific mortality. When a patient has a distant recurrence, the 5-year survival is reduced from 99.0% to 27.3%.1 Therefore, it's critical at the time of diagnosis, to identify patients that need additional treatment and those that do not.

Healthcare Costs

Lack of treatment at the time of misdiagnosis can lead to more treatment at a later date and higher future medical costs if the cancer spreads.2

Ongoing Diagnostic Confidence

The affect of potential misdiagnosis can also affect a physicians’ diagnostic calibration. This is defined by Meyer et al, as the relationship between diagnostic accuracy and confidence in that accuracy. In addition, there can be a reduction in confidence for those that refer to these dermatopathologists.

DecisionDx DiffDx-Melanoma Can Help Reduce This Diagnostic Uncertainty

DiffDx-Melanoma is designed to provide dermatopathologists with a result of either benign or malignant in >96% of lesions receiving a result, giving dermatologists more information to improve patient management decisions.

1 SEER. (2020) Cancer Stat Facts: Melanoma of the Skin. https://seer.cancer.gov/statfacts/html/melan.html. 2 Guy, et al., Am J Prev Med. 2012 November ; 43(5): 537-545. doi:10.1016/j.amepre.2012.07.031. 

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