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Scientific evidence
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
23-gene expression profile (GEP) testing for diagnosis of cutaneous melanocytic lesions in a Medicare-eligible population
Mar 2024
The high accuracy and clinical utility of the 23-GEP test demonstrated across multiple prior studies are applicable to the Medicare-eligible population.
Publication: Poster, presented at the 2023 College of American Pathologist (CAP) Annual Meeting
Inconsistent associations between risk factor profiles and adjuvant radiation therapy (ART) treatment in patients with cutaneous squamous cell carcinoma and utility of the 40-gene expression profile to refine ART guidance
Mar 2024
ART guidance is not determined by the presence of specific clinicopathologic factors, with treated and untreated patients sharing the same risk factor profiles. cSCC risk determination based on NCCN recommendations for clinical factor assessment results in inconsistent use of ART. Including tumor biology-based prognostic information from the 40-GEP refines risk and identifies patients who are most appropriate and likely to benefit from ART, and those that can consider deferring ART
Publication: Dermatology and Therapy
Integrating the 40-gene expression profile (40-GEP) test improves metastatic risk-stratification within clinically relevant subgroups of high-risk cutaneous squamous cell carcinoma (cSCC) patients
Mar 2024
The 40-GEP test demonstrates accurate, independent, clinically actionable stratification of metastatic risk and improves predictive accuracy when integrated into risk classification systems. The improved accuracy of risk assessment when including tumor biology via the 40-GEP test ensures more risk-aligned, personalized patient management decisions.
Publication: Dermatology and Therapy
Integrating 40-GEP testing to improve clinical recommendations for adjuvant radiation for cutaneous squamous cell carcinoma: multidisciplinary consensus guidelines
Feb 2024
Combining clinicopathologic staging with the 40-GEP test allows for more accurate prognostic staging of cSCC tumors; this, in turn, improves precision in multidisciplinary treatment recommendations, including the use of ART. The utility of 40-GEP testing has been demonstrated in low-, higher-, and highest-stage cSCC tumors. Additionally, 40-GEP testing has shown greater specificity than current clinicopathologic guidelines in identifying patients at highest risk of nodal or distant metastasis who would most likely benefit from ART, as well as lower risk patients who would benefit less from such therapy. Appropriate use of 40-GEP testing involves a shared decision-making model between the multidisciplinary team and the patient with cSCC, taking into consideration many factors, such as the patient’s risk of metastasis, tumor and nontumor characteristics, and individual preferences.
Publication: Journal of Clinical Aesthetic Dermatology
A randomized controlled study on clinical adherence to evidence-based guidelines in the management of simulated patients with Barrett’s esophagus and the clinical utility of a tissue systems pathology test: results from Q-TAB
Jan 2024
TissueCypher optimized adherence to clinical guidelines for surveillance and treatment of both BE patients at high and low risk for disease progression. Use of the test can enable physicians to make risk-aligned management decisions, leading to improved patient health outcomes.
Publication: Clinical and Translational Gastroenterology
Diagnostic discordance among histopathological reviewers for difficult-to- diagnose melanocytic lesions
Jan 2024
Publication: Poster, presented at the 2024 Winter Clinical Dermatology Conference - Hawaii®, Honolulu, Hawaii, January 12-17, 2024
Gene expression differences identified in skin samples of mycosis fungoides, atopic dermatitis, and psoriasis.
Jan 2024
Gene Expression Differences Identified in Skin Samples of Mycosis Fungoides, Atopic Dermatitis, and Psoriasis.
Publication: Poster, presented at the 2024 Winter Clinical Dermatology Conference - Hawaii®, Honolulu, Hawaii, January 12-17, 2024
The 40-gene expression profile (40-GEP) test identifies cutaneous squamous cell carcinoma (cSCC) patients at high risk of metastasis within lower-staged tumors to better guide treatment decisions
Jan 2024
Publication: Poster, presented at the 2024 Winter Clinical Dermatology Conference - Hawaii®, Honolulu, Hawaii, January 12-17, 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
Use of the 40-gene expression profile (40-GEP) test in medicare-eligible patients diagnosed with cutaneous squamous cell carcinoma (cSCC) to guide adjuvant radiation therapy (ART) decisions leads to a significant reduction in healthcare costs
Jan 2024
Utilizing the 40-GEP test results to guide ART decision-making would result in material savings to Medicare.
Publication: Journal of Clinical and Aesthetic Dermatology
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