MyPath Melanoma | Castle Biosciences

Increased clarity for difficult-to-diagnose melanocytic lesions

MyPath Melanoma gene expression profile (GEP) test is designed to provide objective information to aid in the diagnosis and to inform management decisions for patients with ambiguous melanocytic lesions.

Actionable results for clinicians and pathologists

MyPath Melanoma was validated in cutaneous melanocytic lesions to accurately differentiate between benign and malignant melanocytic lesions of unknown potential, based on the expression of 23 genes using standard quantitative qRT-PCR that provides an accurate and objective classification suggestive of benign, intermediate, or malignant. The actionable results enable:

Increased clarity in pathology reports
More informed patient management decisions
IMPROVED DIAGNOSTIC AND CLINICAL CONFIDENCE

Ambiguity creates problems for patient management decisions

It is estimated that there are more than two million biopsies of suspected melanoma annually in the U.S. Approximately 85 percent 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. Rates of diagnostic discordance vary with the types and complexity of the lesion in review but have been reported at 35-63% for lesions in the middle of the diagnostic spectrum where the malignant potential is less clear.

The impact can be significant

Under-treatment of melanoma can lead to tumor spread and greatly increases the risk of melanoma-specific mortality. When a patient has a distant recurrence, the five-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.

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).

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.