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

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

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

Diagnostic utility of the 23-gene expression profile test for an atypical intradermal melanocytic proliferation

Dec 2023

A case report describing how MyPath GEP testing leads to diagnostic clarity in a histopathologically ambiguous melanocytic lesion on the face of a 34-year-old man.

Author: Marks E, et al.

Publication: Future Medicine

A physician’s guide to the use of gene expression profile ancillary diagnostic testing for cutaneous melanocytic neoplasms

Dec 2023

Author: Marks E, et al.

Publication: Journal of Clinical and Aesthetic Dermatology

A Physician’s Guide to the Use of Gene Expression Profile Ancillary Diagnostic Testing for Cutaneous Melanocytic Neoplasms

Dec 2023

A real-world assessment of common use scenarios of MyPath GEP testing by dermatopathologists and dermatologists to achieve definitive diagnoses and personalized patient management plans.

Author: Marks E, et al.

Publication: Journal of Clinical and Aesthetic Dermatology

Performance of the 23-gene expression profile (23-GEP) test by histopathological evaluation in an independent, multi-center performance cohort of cutaneous melanocytic neoplasms

Nov 2023

Accuracy data in an independent, multi-center cohort of 2512 melanocytic lesions

Author: Goldberg M, et al.

Publication: Skin

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

Abnormally pigmented lesion with uncertain malignant potential

Jun 2023

With benign GEP results, dermatopathologist adjusts diagnosis to a benign neoplasm and patient avoids re-excision.

Asymmetrical pigmented lesion with high clinical suspicion for melanoma

Jun 2023

A 27-year-old female patient was seen by a primary care physician who recommended follow-up with a dermatologist for assessment of a concerning melanocytic lesion.