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.

Author: Shawn Young, MD, et al.

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.

Author: J. Michael Guenther, MD

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

An Automated Tissue Systems Pathology Test Can Standardize the Management and Improve Health Outcomes for Patients with Barrett's Esophagus

Nov 2023

Management guided by the TissueCypher test can standardize care plans by increasing the early detection of progressors who can receive therapeutic interventions, while also increasing the percentage of nonprogressors who can avoid unnecessary therapy and be managed by surveillance alone.

Author: Duits, Lucas C, et al.

Publication: American Journal of Gastroenterology

A Tissue Systems Pathology Test Outperforms the Standard of Care Variables in Predicting Progression in Patients with Barrett’s Esophagus

Nov 2023

This study evaluated the predictive performance of TissueCypher versus current clinicopathologic variables in a multi-center cohort of BE patients.

Author: Davison JM, et al.

Publication: Clinical and Translational Gastroenterology

The Tissue Systems Pathology Test Outperforms Pathology Review in Risk-Stratifying Patients with Low-Grade Dysplasia

Nov 2023

This study aimed to compare the risk stratification performance of the TissueCypher test vs benchmarks of generalist and expert pathology.

Author: Khoshiwal AM, et al.

Publication: Gastroenterology

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

A Tissue Systems Pathology Test Enables Risk-Aligned Management of Patients with Non-Dysplastic Barrett’s Esophagus: Case Reports from a Gastrointestinal Surgery Center

Sep 2023

TissueCypher demonstrated clinical utility in NDBE patients by guiding risk-aligned upstaging of care and potential improved health outcomes in BE patients.

Author: Tseng D, et al.

Publication: Poster presentation (61) at AFS 2023, Dallas

The tissue systems pathology-9 test provides clinically-impactful risk stratification in patients with Barrett’s esophagus: clinical experience in a multicenter cohort

Aug 2023

This study evaluated the use of the validated, commercially-available tissue systems pathology test (TissueCypher, TSP-9) to risk-stratify BE patients in a large clinical practice cohort.

Author: Villa NA, et al.

Publication: Diseases of the Esophagus

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 CN, 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