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Scientific evidence
Prospective multicenter clinical impact evaluation of a 31-gene expression profile test for management of melanoma patients
Mar 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.
Publication: SKIN: Journal of Cutaneous Melanoma
Analytic validity of DecisionDx-Melanoma, a gene expression profile test for determining metastatic risk in melanoma patients
Feb 2018
Study was designed to assess the analytical validity of the 31-GEP test.
Publication: Diagnostic Pathology
Performance of a prognostic 31-gene expression profile in an independent cohort of 523 cutaneous melanoma patients
Feb 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.
Publication: BMC Cancer
Impact of gene expression profiling on decision-making in clinically node negative melanoma patients after surgical staging
Feb 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.
Publication: Journal of Drugs and Dermatology
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
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
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
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
Development of a prognostic genetic signature to predict the metastatic risk associated with cutaneous melanoma
Jan 2015
Multicenter study shows clear and significant separation of risk between Class 1 and Class 2 result for DFS, DMFS, MSS, OS using Kaplan-Maier analysis.
Publication: Clinical Cancer Research