Scientific Evidence

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.

Author: Gregory A. Holzer, MD, PhD, et al.

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.

 

Author: Sherrif Ibrahim, MD, PhD, et al.

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.

Author: Alexander Witkowski, MD, PhD, et al.

Publication: Future Medicine

Pharmacogenomic characteristics and IDgenetix-guided medication management for older adults with depression and anxiety

Mar 2024

This study showed that the drug-drug interactions and lifestyle factors provided by Castle Biosciences’ IDgenetix® test significantly improved medication recommendations over drug-gene interactions alone for patients 65 and older.

Author: Cao F, Lorenz R, Hanson E, Cook R

Publication: Poster at AAGP 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.

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

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.

Author: Jose A Plaza, MD, et al.

Publication: Poster, presented at the 2023 College of American Pathologist (CAP) Annual Meeting

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.  

Author: Peabody JW, et al.

Publication: Clinical and Translational Gastroenterology

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

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.

Author: Farberg A, et al.

Publication: Poster, presented at the 2024 Winter Clinical Dermatology Conference - Hawaii®, Honolulu, Hawaii, January 12-17, 2024

Diagnostic discordance among histopathological reviewers for difficult-to- diagnose melanocytic lesions

Jan 2024

Author: Hosler G, et al.

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.

Author: Podlipnik S, et al.

Publication: Cancers