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Scientific evidence
Integrating skin cancer–related technologies into clinical practice
Oct 2017
11-member Melanoma Evolving Diagnostic Technologies Integration Group (MEDTIG) derived an algorithmic approach to systematically facilitate incorporating these technologies into the evaluation and management of suspicious PSLs.
Publication: Dermatologic Clinics
Interim analysis of survival in a prospective, multi-center registry cohort of cutaneous melanoma tested with a prognostic 31-gene expression profile test
Aug 2017
Prospective evaluation of the GEP performance in patients enrolled in two clinical registries for three primary endpoints recurrence-free (RFS), distant metastasis-free (DMFS), and overall survival (OS).
Publication: Journal of Hematology and Oncology
Diagnostic distinction of malignant melanoma and benign nevi by a gene expression signature and correlation to clinical outcomes
Jul 2017
Large outcomes-proven validation cohort establishes high levels of sensitivity and specificity in melanomas with proven distant metastasis and nevi with 6+ years of event free follow-up.
Publication: Cancer Epidemiology, Biomarkers, and Prevention
Impact of a 31-gene expression profiling test for cutaneous melanoma on dermatologists clinical management decisions
May 2017
Risk appropriate management recommendations for implementing SLNB and imaging were more likely to be made following incorporation of DecisionDx-Melanoma test results.
Publication: Journal of Drugs and Dermatology
Identification of high-risk cutaneous melanoma tumors is improved when combining the online American Joint Committee on Cancer individualized melanoma patient outcome prediction tool with a 31-gene expression profile–based classification
May 2017
Comparison and accuracy of the GEP in combination with risk determined using the web-based AJCC Individualized Melanoma Patient Outcome Prediction Tool.
Publication: Journal of the American Academy of Dermatology
The influence of a gene expression signature on the treatment of diagnostically challenging melanocytic lesions
Jan 2017
MyPath Melanoma guides dermatologists in treatment decisions leading to a 72% reduction in re-excisions when the GEP result is benign.
Publication: Personalized Medicine
An independent validation of a gene expression signature to differentiate malignant melanoma from benign melanocytic nevi
Oct 2016
Establishes the performance of the gene expression signature in prospectively submitted cases with triple concordant diagnosis.
Publication: Cancer
The influence of a gene expression signature on the diagnosis and recommended treatment of melanocytic tumors by dermatopathologists
Oct 2016
Definitive diagnoses by dermatopathologists in challenging melanocytic lesions increased by 57% by incorporating the results of 23-GEP.
Publication: Medicine
Clinical impact of a 31-gene expression profile test for cutaneous melanoma in 156 prospectively and consecutively tested patients
May 2016
Post-test management plans were changed in 53% of patients who had risk aligned management changes concordant with a Class 1 (low risk) or Class 2 result (high risk).
Publication: Current Medical Research and Opinion
Clinical validation of a gene expression signature that differentiates benign nevi from malignant melanoma
Mar 2015
Initial development and validation of the 23-GEP establishing a high level of sensitivity and specificity in a broad range of histopathological subtypes.
Publication: Journal of Cutaneous Pathology
Gene expression profiling for molecular staging of cutaneous melanoma in patients undergoing sentinel lymph node biopsy
Mar 2015
Assessment of the prognostic accuracy of GEP and sentinel lymph node biopsy (SLNB) tests, independently and in combination, in a multicenter cohort of 217 patients.
Publication: Journal of the American Academy of Dermatology
Analytical validation of a melanoma diagnostic gene signature using formalin-fixed paraffin-embedded melanocytic lesions
Mar 2015
Analytical validation study to establish precision, dynamic range, RNA yield, reproducibility, and melanin inhibition.
Publication: Biomarkers in Medicine