Strong association between long-term clinical outcomes and gene expression signature

“Although previous studies have evaluated the gene expression against the current “gold” standard for melanoma diagnosis, histopathology, there are known limitations with diagnostic concordance among dermatopathologists. Another approach is to validate the gene signature against long-term clinical outcomes.”

Ko JS, et al. Correlation of melanoma gene expression score with clinical outcomes on a series of melanocytic lesions. Human Pathol. 2019; 86:213-221.

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myPath Melanoma performs best against true clinical outcomes.

“The results of gene expression testing closely correlate with long-term clinical outcomes of patients with melanocytic neoplasms. The gene expression score differentiated melanoma from nevi with a sensitivity of 93.8% and a specificity of 96.2%.”

Ko JS, et al. Diagnostic distinction of malignant melanoma and benign nevi by a gene expression signature and correlation to clinical outcomes. Cancer Epidemiol Biomarkers Prev 2017; accepted on Feb 28, 2017.

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myPath Melanoma is shown to have a high level of accuracy.

“The gene signature assessed here is intended to provide adjunctive information for the diagnosis of melanoma in ambiguous and difficult-to-diagnose lesions. The prospective cohort used in this study included numerous melanoma and nevus subtypes, including some types known to present significant diagnostic challenges in the clinical setting.”

Clarke LE, et al. An independent validation of a gene expression signature to differentiate malignant melanoma from benign melanocytic nevi. Cancer 2017 Feb; 123(4): 617-28; doi: 10.1002/cncr.30385.

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myPath Melanoma provides additional, unique information beyond histopathology.

“Using quantitative reverse-transcription polymerase chain reaction (PCR) on a selected set of 23 differentially expressed genes, and by applying a threshold value and weighting algorithm, we developed a gene expression signature that produced a score that differentiated benign nevi from malignant melanomas. […] The performance, objectivity, reliability and minimal tissue requirements of this test suggest that it could have clinical application as an adjunct to histopathology in the diagnosis of melanocytic neoplasms.”

Clarke LE, et al. Clinical validation of a gene expression signature that differentiates benign nevi from malignant melanoma. J Cutan Pathol 2015; 42:244-5.

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