

Scientific evidence
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Factors Affecting Dermatologists' Use of a 31-Gene Expression Profiling Test as an Adjunct for Predicting Metastatic Risk in Cutaneous Melanoma
May 1, 2018
Survey and clinical vingettes to determine the impact of three factors - Breslow thickness, ulceration, and sentinel lymph node biopsy status - on the decision to order the 31-GEP test.
DecisionDx-Melanoma
Cutaneous Melanoma
Clinical Utility
Prognostic
Dermatology
Publication
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Prospective, Multicenter Clinical Impact Evaluation of a 31-Gene Expression Profile Test for Management of Melanoma Patients
March 9, 2018
Initital data from a prospective study assessing the impacy of 31-GEP testing results on clinical management decisions including changes in imaging, laboratory work, and frequency of office visits.
DecisionDx-Melanoma
Cutaneous Melanoma
Clinical Utility
Prognostic
Dermatology
Publication
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Analytic validity of DecisionDx-Melanoma, a gene expression profile test for determining metastatic risk in melanoma patients
February 13, 2018
Study was designed to assess the analytical validity of the 31-GEP test.
DecisionDx-Melanoma
Cutaneous Melanoma
Validation
Prognostic
Dermatology
Publication
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Guidelines of care for the management of cutaneous squamous cell carcinoma
February 12, 2018
Cutaneous squamous cell carcinoma (cSCC) is the second most common form of human cancer and has an increasing annual incidence. Although most cSCC is cured with office-based therapy, advanced cSCC poses a significant risk for morbidity, impact on quality of life, and death. This document provides evidence-based recommendations for the management of patients with cSCC.
DecisionDx-SCC
Cutaneous Squamous Cell Carcinoma
Clinical Utility
Prognostic
Dermatology
Publication
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Performance of a prognostic 31-gene expression profile in an independent cohort of 523 cutaneous melanoma patients
February 5, 2018
Multicenter study using GEP was used in combination with SLNB to enhance identification of patients with high-risk melanoma. GEP predicted additional recurrences and distant metastases, improving sensitivity over using SLNB alone.
DecisionDx-Melanoma
Cutaneous Melanoma
Clinical Utility
Prognostic
Dermatology
Publication
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Impact of Gene Expression Profiling on Decision-Making in Clinically Node Negative Melanoma Patients after Surgical Staging
February 1, 2018
Assesed impact of GEP results on the management of clinically node negative cutaneous melanoma patients staged with sentinel lymph node biopsy (SLNB). 31-GEP was significantly associated with the management of stage I-II melanoma patients after staging with SLNB. Node negative Class 2 patients led to more aggressive management.
DecisionDx-Melanoma
Cutaneous Melanoma
Clinical Utility
Prognostic
Dermatology
Publication
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Systems Biology Approaches in Cancer Pathology
January 1, 2018
A method for objective quantification of epithelial and stromal biomarkers to generate a tissue profile aiding predictive models for cancer pathology.
TissueCypher
Barrett's Esophagus
Review Article
Prognostic
Gastroenterology
Publication
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Gene expression signature as an ancillary method in the diagnosis of desmoplastic melanoma
December 1, 2017
Assessment of the sensitivity and specificity of 23-GEP in melanocytic lesions with a desmoplastic component
MyPath Melanoma
DiffDx-Melanoma
Cutaneous Melanoma
Validation
Diagnostic
Dermatology
Publication
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Integrating Skin Cancer–Related Technologies into Clinical Practice
October 1, 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.
DecisionDx-Melanoma
Cutaneous Melanoma
Review Article
Prognostic
Dermatology
Publication
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Interim analysis of survival in a prospective, multi-center registry cohort of cutaneous melanoma tested with a prognostic 31-gene expression profile test
August 29, 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).
DecisionDx-Melanoma
Cutaneous Melanoma
Clinical Utility
Prognostic
Dermatology
Publication
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Diagnostic Distinction of Malignant Melanoma and Benign Nevi by a Gene Expression Signature and Correlation to Clinical Outcomes
July 1, 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
MyPath Melanoma
DiffDx-Melanoma
Cutaneous Melanoma
Validation
Diagnostic
Dermatology
Publication
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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 1, 2017
Comparison and accuracy of the GEP in combination with risk determined using the web-based AJCC Individualized Melanoma Patient Outcome Prediction Tool
DecisionDx-Melanoma
Cutaneous Melanoma
Other
Prognostic
Dermatology
Publication
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