Castle Biosciences, Inc. will present new data across its dermatologic portfolio of commercially available and pipeline gene expression profile (GEP) tests at the 2024 Winter Clinical Dermatology Conference - Hawaii, being held Jan. 12-17 in Honolulu, Hawaii. Highlights from Castle?s posters at Winter Clinical ?

Hawaii are included below. Posters will be displayed for viewing in the Coral Ballroom 2 through Jan. 16 at 1 p.m. Hawaii Standard Time.

DecisionDx-Melanoma: Real-world evidence confirms risk stratification of the 31-GEP and i31-GEP in prospectively tested patients with stage I-III cutaneous melanoma Summary: To further advance patient care, Castle?s DecisionDx-Melanoma test result, based on a patient?s tumor biology, was integrated with clinical and pathological factors using a validated proprietary algorithm (i31-GEP for risk of recurrence, or ROR). The i31-GEP ROR provides a more personalized, precise risk of tumor recurrence to guide clinical management of CM. This study aimed to validate the DecisionDx-Melanoma test and i31-GEP ROR algorithm in a real-world cohort of patients with stage I-III CM (n=1,831) who received the DecisionDx-Melanoma test as part of their routine clinical care.

The study confirmed the independent and significant risk-stratification provided by DecisionDx-Melanoma and its integrated i31-GEP ROR algorithm, identifying patients at high risk of melanoma recurrence to guide important, risk-appropriate interventions, such as imaging surveillance and immunotherapy, that can potentially improve patient outcomes. 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. Summary: This study evaluated the ability of DecisionDx-SCC to independently improve the identification of lower-staged tumors at increased risk of metastasis.

Improved risk assessment in these lower-staged subsets is important as up to one-third of all metastatic events have been reported for patients originally staged with T1 tumors. Within a cohort of SCC patients considered lower risk by current staging alone, DecisionDx-SCC identified those at a substantially higher risk of metastasis. These results represent a clinically significant improvement in risk assessment for SCC patients with observed rates of metastasis over 10% and 20%, respectively, which are clinically actionable for nodal staging or post-operative adjuvant radiation.

Combining traditional risk classification systems with a patient?s individual biologic risk, as provided by the DecisionDx-SCC test, can improve the accuracy of risk assessment to inform important patient treatment decisions. Diagnostic discordance among histopathological reviewers for difficult-to-diagnose melanocytic lesions. Summary: Diagnostic discordance in cutaneous melanocytic lesions is well documented and prevalent among difficult-to-diagnose cases, for which histopathology may be insufficient for a definitive diagnosis.

MyPath Melanoma testing is available for ambiguous melanocytic neoplasms to add clarity to these diagnoses. This study showed that in a large cohort of patients with suspicious lesions (n=3,317), approximately 24% were difficult to diagnose, supporting the need for an objective diagnostic tool like MyPath Melanoma to aid in providing an accurate diagnosis to help ensure appropriate patient management. Gene expression differences identified in skin samples of mycosis fungoides, atopic dermatitis and psoriasis.

Summary: The goal of Castle?s innovative pipeline initiative is to develop a genomic test aimed at guiding systemic therapy selection for patients with moderate-to-severe atopic dermatitis (AD), PSO and related conditions. The test in development would help personalize therapy selection for patients based on their molecular profile and help determine which therapy may best help to manage their symptoms. At the recent 2023 Fall Clinical Dermatology Conference®, Castle presented data [4] showing the ability of its pipeline test in development to identify distinct gene expression profiles of super-responders to an AD therapy and also distinguish between AD, PSO and mycosis fungoides (MF) skin lesions. Castle?s poster at Winter Clinical ?

Hawaii builds on this data by showing the ability of the pipeline test in development to determine the gene expression profile of super-responders to a PSO therapy.