Scientific Evidence

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.

Author: Gastman B, et al.

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.

Author: Greenhaw B, et al.

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.

Author: Mirsky R, et al.

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.

Author: Svoboda RM, et al.

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.

Author: Dillon LD, et al.

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.

Author: Cook RW, et al.

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.

Author: Zager J, et al.

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.

Author: Schuitevoerder D, et al.

Publication: Journal of Drugs and Dermatology

Gene expression signature as an ancillary method in the diagnosis of desmoplastic melanoma

Dec 2017

Assessment of the sensitivity and specificity of 23-GEP in melanocytic lesions with a desmoplastic component.

Author: Clarke LE, et al.

Publication: Human Pathology

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.

Author: Winkelmann R, et al.

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).

Author: Hsueh E, et al.

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.

Author: Ko J, et al.

Publication: Cancer Epidemiology, Biomarkers, and Prevention