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Comparing two gene expression profile tests to standard of care for identifying patients with cutaneous melanoma at low risk of sentinel lymph node positivity
May 2025
Two gene expression profile (GEP) tests, the CP-GEP and the 31-GEP, have been developed to identify patients at low risk of SLN positivity who may consider avoiding SLNB. We analyzed the accuracy of the CP-GEP and 31-GEP in identifying patients with <5% risk of SLN positivity across the five validation studies of the CP-GEP and four validation studies of the 31-GEP in T1-T2 tumors.
Publication: Cancer Diagnosis and Prognosis
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