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Scientific evidence
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
The 40-gene expression profile (40-GEP) test enhances risk-aligned guidance for surveillance imaging in high-risk cutaneous squamous cell carcinoma (cSCC)
Oct 2024
Publication: Presented at the 2024 American Society for Dermatologic Surgery (ASDS) Annual Meeting
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
Appropriate statistical methods to assess cross-study diagnostic 23-gene expression profile test performance for cutaneous melanocytic neoplasms
Aug 2024
MyPath Melanoma has been well studied over the past nine years in various independent and company-sponsored studies. This publication re-analyzes data from multiple previous performance studies of MyPath Melanoma using a rigorous, standardized method for statistical analysis across studies. Goldberg et al. use a mathematical bootstrapping technique to correct for small, imbalanced, and inconsistent cohort sizes across studies allowing for direct comparison between all studies. The resulting analysis not only found consistently high sensitivity, specificity, positive predictive value, and negative predictive value, but also found no statistically significant difference in performance across both independent and company-sponsored studies.
Publication: American Journal of Dermatopathology
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
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
Jul 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
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
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