Abstract
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Highlights
› Diagnostic discordance in suspicious cutaneous melanocytic lesions is well documented and prevalent among difficult-to-diagnose cases, for which histopathology may be insufficient for a definitive diagnosis.[1,2,3,4]
› Here, we report test result metrics from archival research cases and from this clinical workflow
Cases with Intermediate or Technical Fail results from the 23-gene expression profile (GEP) undergo testing with the 35-GEP
Summary
› Diagnostic discordance in suspicious cutaneous melanocytic lesions is well documented and prevalent among difficult-to-diagnose cases, for which histopathology may be insufficient for a definitive diagnosis.[1,2,3,4]. › The 23-gene expression profile (GEP; myPath Melanoma) and 35-GEP (DiffDx-Melanoma) tests are clinically available objective ancillary tools that facilitate diagnosis of melanocytic lesions with ambiguous histopathology. The tests use proprietary algorithms to produce results of likely benign, intermediate, or malignant.[5,6,7]. › The 23-GEP has shown accuracy metrics of over 90% sensitivity in multiple clinical studies that included patient outcomes.[8,9,10] the 23-GEP historically has resulted in ~23% of cases receiving either a technical failure or an intermediate result, which can be perceived as nonactionable.[6,11,12,13] The 35-GEP test can address this shortcoming and showed both an increased sensitivity in the first validation cohort and a decreased nonactionable rate of 8.5%.7. › Clinical utility has been demonstrated with benign and malignant GEP test results;[11,14] those test results are defined as actionable
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