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Scientific evidence
Predicting adjuvant radiation therapy benefit in cutaneous squamous cell carcinoma with the 40-gene expression profile
Sep 2024
The 40-GEP identified patients most likely to benefit from ART (Class 2B) and those that can consider deferring treatment (Class 1).
Publication: Future Oncology
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
The tissue systems pathology test objectively risk-stratifies patients with Barrett’s esophagus results from a multicenter US clinical experience study
Jul 2024
This study highlights the clinical experience of TissueCypher testing ordered by 891 physicians in over 8,000 patients. This real-world clinical use of TissueCypher reflects the U.S. BE surveillance population with a significant proportion (93.9%) of diagnosed cases having NDBE and 94.3% of orders originating from community-based practices
Publication: Journal of Clinical Gastroenterology
Diagnostic discordance among histopathological reviewers of melanocytic lesions
May 2024
The management of patient with melanocytic lesions is dependent on the diagnosis with guidelines defining treatment protocols for benign nevi and malignant melanomas. Even though diagnostic discordance and diagnostic ambiguity have been previously established, the real-world impact on patient management is not well understood.Using an exhaustive review process by multiple dermatopathologists and a simulated patient treatment model, this study reveals that diagnostic discordance and ambiguity may be more common that previously reported and identifies significant variation in patient treatment in these lesions.
Publication: Journal of Cutaneous Pathology
Addition of the 40-gene expression profile (40-GEP) test improves prognostic accuracy and risk stratification for high-risk cutaneous squamous cell carcinoma (HR-cSCC) of the head and neck treated with Mohs micrographic surgery (MMS)
May 2024
Assess the ability of the 40-GEP test to significantly improve metastatic risk prediction of NCCN, AJCC8, and BWH staging systems when included.
Publication: Poster, presented at the American College of Mohs Surgery 2024
Association of a 40-gene expression profile with risk of metastatic disease progression of cutaneous squamous cell carcinoma (cSCC) and specification of benefit of adjuvant radiation therapy
May 2024
DecisionDx-SCC identifies patients at the highest risk of nodal/distant metastasis who may derive the greatest benefit from ART, as well as patients who may have clinical indications for ART but are at low risk of metastasis. Compared with current guidelines, 40-GEP could provide greater specificity concerning the benefit of ART in individual patients.
Publication: International Journal of Radiation Oncology, Biology, Physics
A clinical impact study of dermatologists' use of diagnostic gene expression profile testing to guide patient management
Apr 2024
Diagnostic GEP tests help guide clinical decision-making in a variety of diagnostically ambiguous or clinicopathologically discordant scenarios.
Publication: Future Medicine
Pharmacogenomic characteristics and IDgenetix-guided medication management for older adults with depression and anxiety
Mar 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
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
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