On July 7, 2023 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported that it will present new data on its gene expression profile (GEP) risk-stratification test for patients with cutaneous squamous cell carcinoma (SCC), DecisionDx-SCC, and its GEP risk-stratification test for patients with cutaneous melanoma (CM), DecisionDx-Melanoma, at the American Head & Neck Society’s (AHNS) 11th International Conference on Head and Neck Cancer, being held July 8-12 in Montréal, QC, Canada (Press release, Castle Biosciences, JUL 7, 2023, View Source [SID1234633114]).

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Castle’s podium presentation on DecisionDx-SCC will share data demonstrating significantly improved metastatic risk prediction in patients with SCC of the head and neck (SCC-HN) when the test’s results are used both independently and in conjunction with American Joint Committee on Cancer 8th edition (AJCC8) and Brigham and Women’s Hospital (BWH) staging systems. Details are as follows:

Abstract ID: 128656 | Podium presentation: Improved metastatic risk prediction with the 40-gene expression profile (40-GEP) test supports its use for risk-aligned decision making for patients with high-risk cutaneous squamous cell carcinoma of the head and neck
Presenter and Study Author: Jason G. Newman, M.D., F.A.C.S., Department of Otolaryngology Head and Neck Surgery at Medical University of South Carolina
Session Date/Time: Sunday, July 9, 1:45-3:15 p.m. Eastern time
Session Name: Proffered Papers 9 – Skin 1 and Hot Topic Session

"Traditional staging methods rely on a limited set of clinicopathologic risk factors to categorize cancer patients into different stages," said Newman. "While these factors provide important information, they may not fully capture the underlying biological heterogeneity and variability in tumor behavior. The study data demonstrated that using DecisionDx-SCC test results in combination with these traditional staging approaches can improve prognostic accuracy to help optimize and personalize treatment choices based on a patient’s unique, biological risk profile."

This multi-center study expands on a previously published study1 and analyzed data from 622 patients with high-risk SCC-HN. In the study, DecisionDx-SCC significantly stratified patients according to their biologic risk of metastasis, independent of the clinicopathologic risk factors used in AJCC8 and BWH staging systems (p<0.0001). Additionally, the metastatic risk predictions provided by AJCC8 and BWH staging were significantly improved when DecisionDx-SCC test results were included. The data show that DecisionDx-SCC contributes independent prognostic value to the prediction of metastatic risk in SCC-HN patients, relative to staging alone, which can help clinicians make informed decisions regarding treatment and follow-up care. These may include closer monitoring, more frequent imaging scans and the timely initiation of adjuvant treatments to mitigate metastatic risk and improve patient outcomes.

Castle will also present a poster highlighting data from a large study of real-world, unselected patients with head and neck CM (n=985) showing that combining DecisionDx-Melanoma test results with AJCC8 staging significantly improved risk prediction over either alone.

Abstract ID: 128718 | Poster presentation: The 31-gene expression profile test stratifies melanoma-specific survival among patients with head and neck cutaneous melanoma tumors: A Surveillance, Epidemiology, and End Results (SEER) Program Collaboration
Presenter and Study Author: Matthew Goldberg, M.D., Senior Vice President, Medical, Castle Biosciences
Poster Viewing Dates and Times:

Sunday, July 9, 5:15-6:45 p.m. (Welcome Reception)
Monday, July 10, 10 a.m. – 4 p.m. and 5:30-7 p.m. (Wine and Cheese Poster Walk)
Tuesday, July 11, 10 a.m. – 4 p.m.
In the study, DecisionDx-Melanoma testing and AJCC8 staging were independent predictors of mortality. The DecisionDx-Melanoma test classified 40% of the patients as having an increased risk of dying from their disease (Class 1B-2B test result) compared to 15% who were classified as having an increased risk by AJCC8 staging (IIB-III). Overall, the data demonstrated that combining the test’s results with AJCC8 staging significantly improved risk prediction over use of either alone, providing actionable information that can enable risk-aligned patient care.

About DecisionDx-SCC

DecisionDx-SCC is a 40-gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous squamous cell carcinoma metastasis for patients with one or more risk factors. The test result, in which patients are stratified into a Class 1 (low), Class 2A (moderate) or Class 2B (high) risk category, predicts individual metastatic risk to inform risk-appropriate management. Peer-reviewed publications have demonstrated that DecisionDx-SCC is an independent predictor of metastatic risk and that integrating DecisionDx-SCC with current prognostic methods can add positive predictive value to clinician decisions regarding staging and management.

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile risk stratification test. It is designed to inform two clinical questions in the management of cutaneous melanoma: a patient’s individual risk of sentinel lymph node (SLN) positivity and a patient’s personal risk of melanoma recurrence and/or metastasis. By integrating tumor biology with clinical and pathologic factors using a validated proprietary algorithm, DecisionDx-Melanoma is designed to provide a comprehensive and clinically actionable result to guide risk-aligned patient care. DecisionDx-Melanoma has been shown to be associated with improved patient survival and has been studied in more than 10,000 patient samples. DecisionDx-Melanoma’s clinical value is supported by more than 40 peer-reviewed and published studies, providing confidence in disease management plans that incorporate the test’s results. Through March 31, 2023, DecisionDx-Melanoma has been ordered more than 128,000 times for patients diagnosed with cutaneous melanoma.

More information about the Castle’s tests can be found at www.CastleTestInfo.com.