

Scientific evidence
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Level of Evidence Review for a Gene Expression Profile Test for Cutaneous Melanoma
July 29, 2019
Review the current literature and establish the level of evidence for a cutaneous melanoma 31-GEP test.
DecisionDx-Melanoma
Cutaneous Melanoma
Guidelines
Prognostic
Dermatology
Publication
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Establishing an evidence-based decision point for clinical use of the 31-gene expression profile test in cutaneous melanoma
July 8, 2019
Multi center study establishing appropriate use criteria for determining risk of recurrence in patients
with tumors >0.3mm in thickness
DecisionDx-Melanoma
Cutaneous Melanoma
Validation
Prognostic
Dermatology
Publication
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Independent validation of a tissue systems pathology test to predict progression Barrett’s esophagus patients (PODIUM PRESENTATION AT DDW 2019, SAN DIEGO 1068)
May 1, 2019
TissueCypher identifies NDBE patients who are at increased risk for progression to HGD/EAC and may benefit from increased surveillance or early intervention.
TissueCypher
Barrett's Esophagus
Validation
Prognostic
Gastroenterology
Presentation
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Prospective validation of the prognostic 31-gene expression profiling test in primary cutaneous melanoma
April 5, 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.
DecisionDx-Melanoma
Cutaneous Melanoma
Validation
Prognostic
Dermatology
Publication
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Correlation of melanoma gene expression score with clinical outcomes on a series of melanocytic lesions
April 1, 2019
Clinical validation study of the 23-GEP in lesions with clinical outcomes and follow-up data
MyPath Melanoma
DiffDx-Melanoma
Cutaneous Melanoma
Validation
Diagnostic
Dermatology
Publication
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Early outcome of a 31-gene expression profile test in 86 AJCC stage IB-II melanoma patients. A prospective multicentre cohort study
January 31, 2019
Multicentre evaluation the early prognostic performance of a genetic signature in a multicentre prospectively evaluated cohort.
DecisionDx-Melanoma
Cutaneous Melanoma
Validation
Prognostic
Dermatology
Publication
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Performance of a 31-gene expression profile test in cutaneous melanomas of the head and neck
January 29, 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.
DecisionDx-Melanoma
Cutaneous Melanoma
Validation
Prognostic
Dermatology
Publication
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Guidance of sentinel lymph node biopsy decisions in patients with T1–T2 melanoma using gene expression profiling
January 29, 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.
DecisionDx-Melanoma
Cutaneous Melanoma
Clinical Utility
Prognostic
Dermatology
Publication
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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
January 1, 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.
DecisionDx-Melanoma
Cutaneous Melanoma
Validation
Prognostic
Dermatology
Publication
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Estimation of Prognosis in Invasive Cutaneous Melanoma: An Independent Study of the Accuracy of a Gene Expression Profile Test
December 1, 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.
DecisionDx-Melanoma
Cutaneous Melanoma
Validation
Prognostic
Dermatology
Publication
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Management Decisions Made by Physician Assistants and Nurse Practitioners in Cutaneous Malignant Melanoma Patients: Impact of a 31-Gene Expression Profile Test
November 1, 2018
Survey to determine the impact of 31-GEP test results on management decisions made by dermatology PA/NPs for cutaneous melanoma patients.
DecisionDx-Melanoma
Cutaneous Melanoma
Other
Prognostic
Dermatology
Publication
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Clinical Experience with a Multiplexed Immunofluorescence Tissue Biomarker Assay (Tissue Cypher BE) in the Management of Barrett’s esophagus: A Single Center Experience (POSTER PRESENTATION AT DDW 2018, WASHINGTON DC. Su1109)
June 1, 2018
Use of TissueCypher resulted in clinical “upstaging” occurred in 5 of 46 cases, leading to treatment that otherwise might not be pursued.
TissueCypher
Barrett's Esophagus
Clinical Utility
Prognostic
Gastroenterology
Poster
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