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Scientific evidence
A prospective, multicenter analysis of recurrence-free survival after sentinel lymph node biopsy decisions influenced by the 31-GEP
Apr 2025
Although most patients with cutaneous melanoma (CM) will have a negative sentinel lymph node biopsy (SLNB), up to 20%-30% of these patients will recur. The 31-gene expression profile (31-GEP) test has been prospectively validated to identify patients at low (Class 1A), intermediate (Class 1B/2A), and high (Class 2B) risk of SLN positivity and recurrence.
Publication: Cancer Medicine
A prospective, multicenter analysis demonstrates that the integrated 31-GEP test reduces unnecessary sentinel lymph node biopsies (SLNBs) in patients with cutaneous melanoma
Jan 2025
The study assessed the i31-SLNB risk prediction accuracy in 322 patients with T1-T2 tumors enrolled in a prospective, multicenter study. To determine whether incorporating i31-SLNB into decision-making reduced the number of SLNBs performed, propensity score matching was used to compare outcomes with a non-overlapping cohort where the 31-GEP was not.
Publication: World of Surgical Oncology
The prognostic value of the 31-gene expression profile test in cutaneous melanoma: A systematic review and meta-analysis
Nov 2024
Data from multiple studies was systematically reviewed and analyzed to assess the 31-GEP test’s efficacy in predicting melanoma patient outcomes. Our findings suggest that the 31-GEP test may improve risk prediction when used alongside standard clinical and pathological assessments. By using 31-GEP, physicians may be better able to make more informed decisions about treatment and follow-up care, potentially improving outcomes for melanoma patients.
Publication: Cancers
The i31-GEP identifies patients with T1 cutaneous melanoma who can safely avoid sentinel lymph node biopsy: Results from a prospective, multicenter study
Oct 2024
Publication: Presented at the 2024 American Society for Dermatologic Surgery (ASDS) Annual Meeting
Integrating the melanoma 31-gene expression profile test with clinical and pathologic features can provide personalized precision estimates for sentinel lymph node positivity: an independent performance cohort
Sep 2024
The i31-GEP identified patients with < 5% risk of SLN positivity who could safely forego SLNB. Combining the 31-GEP with clinicopathologic features for a precise risk estimate can help guide risk-aligned patient care decisions for SLNB to reduce the number of unnecessary SLNBs and increase the SLNB positivity yield if the procedure is performed.
Publication: World Journal of Surgical Oncology
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
Prospective 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