Scientific evidence

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.

Author: Kriza C, et al.

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.

Author: Young S, et al.

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.

Author: Guenther J, et al.

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.

Author: Podlipnik S, et al.

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

Author: Pariser D, et al.

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

Author: Tassavor M, et al.

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.

Author: Bailey C, et al.

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.

Author: Dhillon S, et al.

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.

Author: Yamamoto M, et al.

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.

Author: Zakria D, et al.

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.

Author: Martin B, et al.

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.

Author: Zakria D, et al.

Publication: SKIN: Journal of Cutaneous Melanoma