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Scientific Evidence
Utility of 31-gene expression profile test in identifying patients with T1 cutaneous melanoma at high risk of SLN positivity and recurrence
Mar 2024
Demonstrate that the 31-GEP offers significant prognostic value in addition to SLN status to help identify patients at the highest risk of tumor recurrence.
Publication: ePoster at SSO 2024
Prospecive validation of the i31-GEP for cutaneous melanoma to select patients who may consider foregoing SLNB
Mar 2024
This study shares three-year outcomes data from Castle’s prospective, multicenter study of patients with melanoma who were being considered for an SLNB (n=322). In the study, at three years, all patients with a low-risk DecisionDx-Melanoma test result were recurrence free (recurrence free survival of 100%). The performance data shared in this presentation, in conjunction with previous validation and performance studies, show DecisionDx-Melanoma as an accurate and precise clinical tool that can identify patients who may safely forego SLNB, reducing the number of unnecessary SLNBs performed (by ~25% in this study alone) and the associated costs and risks of complications that accompany them.
Publication: Oral Presentation at SSO 2024
The 31-gene expression profile test outperforms AJCC in stratifying risk of recurrence in patients with stage I cutaneous melanoma
Jan 2024
In a head-to-head comparison of DecisionDx-Melanoma to AJCCv8 staging for stage I cutaneous melanoma (CM) patients (n=6,883) two cohorts were analyzed using recurrence-free survival and melanoma-specific survival. Results from the study showed that DecisionDx-Melanoma significantly improved patient risk stratification, independent of AJCC staging in patients. In addition, DecisionDx-Melanoma provided greater separation between high-risk (Class 2B) and low-risk (Class 1A) groups than seen between AJCC stage IA and IB.
Publication: Cancers
Real-world evidence confirms risk stratification of the 31-GEP and i31-GEP in prospectively tested patients with stage I-III cutaneous melanoma
Jan 2024
Publication: Poster, presented at the 2024 Winter Clinical Dermatology Conference - Hawaii®, Honolulu, Hawaii, January 12-17, 2024
The Integrated i31-GEP Test Outperforms the MSKCC Nomogram at Predicting SLN Status in Melanoma Patients
Sep 2023
This study evaluates the performance of DecisionDx-Melanoma and the MSKCC nomogram in a head-to-head study in 465 patients withT1 or T2 tumors and known SLN status
Publication: Anticancer Research
31-Gene Expression Profile Testing in Cutaneous Melanoma and Survival Outcomes in a Population-Based Analysis: A SEER Collaboration
Jun 2023
Study data from Castle Biosciences' collaboration with the National Cancer Institutes SEER program registries.
Publication: JCO-PO
Routine imaging guided by a 31-gene expression profile assay results in earlier detection of melanoma with decreased metastatic tumor burden compared to patients without surveillance imaging studies
Mar 2023
Independent multi-center study demonstrates risk-aligned treatment plans guided by DecisionDx-Melanoma lead to better patient outcomes.
Publication: Archives of Derm Research
The 31-gene expression profile test informs sentinel lymph node biopsy decisions in patients with cutaneous melanoma: results of a prospective, multicenter study
Jan 2023
DecisionDx-Melanoma test results influenced 85% of clinicians’ decisions regarding the SLNB surgical procedure. Use of the test results could help avoid unnecessary procedures in low-risk patients whose tumor biology indicates they could safely forgo the procedure.
Publication: Current Medical Research and Opinion
Incorporating prognostic gene expression profile assays into the management of cutaneous melanoma: an expert consensus panel report
Jan 2023
Expert panel of 6 key opinion leaders in dermatology consensus panel unanimously approved eleven usage guidelines and consensus supporting statements for the appropriate use of GEP testing.
Publication: SKIN: Journal of Cutaneous Melanoma
Improved prognostic guidance by the 31-gene expression profile test for clinical decisions after a negative lymph node for patients with cutaneous melanoma
Jan 2023
Using 31-GEP results to guide clinical management and surveillance based on personalized risk of MSS can direct care, improving patient outcomes.
Publication: Poster, presented at Winter Clinical Dermatolog conference- Hawaii Jan 13-18 2023
The integrated 31-gene expression profile (i31-GEP) test for cutaneous melanoma outperforms a clinicopathologic-only nomogram at identifying patients who can forego sentinel lymph node biopsy
Nov 2022
Comparison of the i31-GEP for SLNB to the MIA nomogram in patients with T1-T2 tumors with complete data (n=582). The precision of each tool to identify patients with <5% SLN positivity risk was analyzed using 95% confidence intervals.
Publication: SKIN: Journal of Cutaneous Melanoma
The integrated 31-gene expression profile test (i31-GEP) for cutaneous melanoma outperforms the CP-GEP at identifying patients who can forego sentinel lymph node biopsy when applying NCCN guidelines
Nov 2022
Study compared the i31-GEP for SLNB with the CP-GEP to identify patients who can safely forego SLNB.
Publication: SKIN: Journal of Cutaneous Melanoma