The myPath® Melanoma test result is a single numerical score that classifies melanocytic lesions as likely benign, likely malignant, or indeterminate. The expression of each of the 23 genes that comprise the signature is measured by qRT-PCR. An algorithm is then applied that assigns a weight to each of the signature components and establishes a threshold value. The algorithm generates a single numerical score which is plotted on a scale that ranges from -16.7 to +11.1. This range was established based on the scores produced by the 437 melanocytic lesions analyzed in the first clinical validation study, and scores within this range will be reported. Scores outside of this range cannot be considered valid and will not be reported.
Distribution of myPath Melanoma Scores
- Scores between -16.1 and -2.1 are reported as ‘likely benign’
- Scores between -2.0 and -0.1 are reported as ‘indeterminate’
- Scores between 0.0 and +11.1 are reported as ‘likely malignant’
An indeterminate zone between −2.0 and -0.1 was introduced as approximately half of all apparent false negative results observed in the clinical validation cohort produced scores in this range.
Three possible results from testing
The myPath Melanoma test is intended as an adjunctive diagnostic tool for use in melanocytic lesions that are difficult to classify by histopathology alone.
The results should be considered within the context of all other available clinical, histopathologic, and molecular data when rendering a final diagnosis. Ordering physicians are encouraged to incorporate the results of the test into their pathology reports in the same manner as for reporting other clinically validated, adjunctive tests.