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Scientific evidence
Establishing an evidence-based decision point for clinical use of the 31-gene expression profile test in cutaneous melanoma
Jul 2019
Multi center study establishing appropriate use criteria for determining risk of recurrence in patients with tumors >0.3mm in thickness.
Publication: SKIN: Journal of Cutaneous Melanoma
Prospective validation of the prognostic 31-gene expression profiling test in primary cutaneous melanoma
Apr 2019
Independent, prospective study with over 3.5 years of follow-up, showing results consistent with previous validation studies with GEP class score as statistically associated with MSS, DMFS and RFS.
Publication: Cancer Medicine
Early outcome of a 31-gene expression profile test in 86 AJCC stage IB-II melanoma patients
Jan 2019
A prospective multicentre cohort study. Multicentre evaluation the early prognostic performance of a genetic signature in a multicentre prospectively evaluated cohort.
Publication: Journal of the European Academy of Dermatology and Venereology
Performance of a 31-gene expression profile test in cutaneous melanomas of the head and neck
Jan 2019
Gene expression profile class and node status stratified tumors into significantly different 5-year survival groups by Kaplan-Meier method and both were independent predictors of recurrence in multivariate analysis.
Publication: Head and Neck
Guidance of sentinel lymph node biopsy decisions in patients with T1–T2 melanoma using gene expression profiling
Jan 2019
Multicenter prospective study in T1-T2 tumors showed combining GEP with Breslow thickness and age can provide a more precise determination of SLN positivity risk.
Publication: Future Oncology
Identification of patients at risk of metastasis using a prognostic 31-gene expression profile in subpopulations of melanoma patients with favorable outcomes by standard criteria
Jan 2019
Discovery of reduced RFS for patients with thin tumors and Class 2B biology and cumulative validation cohort for DecisionDx-Melanoma. DecisionDx-Melanoma was the strongest independent predictor of RFS, DMFS and MSS.
Publication: Journal of the American Academy of Dermatology
Estimation of prognosis in invasive cutaneous melanoma: an independent study of the accuracy of a gene expression profile test
Dec 2018
Independent study of the predictive accuracy of the GEP test, to determine what clinical and histopathologic features predict high-risk classification, and to evaluate how intermediate classes (1B & 2A) performed clinically. Patients with GEP Class 2 result were 22 times more likely to metastasize compared to a Class 1 result.
Publication: Dermatologic Surgery
Management decisions made by physician assistants and nurse practitioners in cutaneous malignant melanoma patients: impact of a 31-gene expression profile test
Nov 2018
Survey to determine the impact of 31-GEP test results on management decisions made by dermatology PA/NPs for cutaneous melanoma patients.
Publication: Journal of Drugs and Dermatology
Factors affecting dermatologists' use of a 31-gene expression profiling test as an adjunct for predicting metastatic risk in cutaneous melanoma
May 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.
Publication: Journal of Drugs and Dermatology
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