Overview of
Difficult-to-Diagnose Melanocytic Lesions

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% (SEER 2020). Therefore, it is 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 later and higher future medical costs if the cancer spreads (Cockburn 2010).

Ongoing Diagnostic Confidence

Ongoing Diagnostic Confidence

The effect of potential misdiagnosis can also affect a physician's 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.

A Definitive Diagnosis Informs Patient Management Decisions

The majority of melanocytic lesions receive a definitive diagnosis after initial H&E evaluation but even for the most expert dermatopathologist, 10-15% of the cases can be difficult to diagnose with an H&E alone and may require ancillary testing or remain uncertain.


For these cases, the treatment plan can also be uncertain.  Obtaining highly accurate, objective ancillary testing can mean the difference between a path of overtreatment or the risk of undertreatment.


NCCN guidelines support the use of ancillary testing, including GEP, for indeterminate melanocytic neoplasm following histopathology.


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Ambiguity and Discordance

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