Clinical Evidence

DiffDx Development & Validation

Validation Study 1:

Estrada SI, Shackelton JB, Cleaver NJ, et al. Development and validation of a diagnostic 35-gene expression profile test for ambiguous or difficult-to-diagnose suspicious pigmented skin lesions. SKIN: J Cutan Med 2020;4:506-22.

  • Retrospective cohort (n=503) representing broad range of clinical and histopathologic subtypes
  • Reference standard: Independent concordant diagnosis by 2 out of 3 expert dermatopathologists
  • Sensitivity = 99.1%; Specificity = 94.3%
DiffDx Chart

Clinical Utility Study 1: 

Farberg AS, Ahmed KL, Bailey CN, et al. A 35-gene expression profile test for use in suspicious pigmented lesions impacts clinical management decisions of dermatopathologists and dermatologists. SKIN: J Cutan Med 2020;4:523-33.

  • Retrospective cohort (n=60 as designated as ambiguous)
  • Dermatopathologists utilized the 35-GEP result to refine their diagnoses in lesions receiving a benign vs. malignant 35-GEP result (82.3% diagnostic downgrade vs. 94.9% diagnostic upgrade, respectively). 

Key Findings: Dermatopathologists


chart (2)

DiffDx-Melanoma has demonstrated high levels of both sensitivity and specificity with a low rate of intermediate results across a wide range of melanocytic subtypes and high rate of technical success.


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