Texas - Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced the publication of an expert consensus article in the Journal of Clinical and Aesthetic Dermatology (JCAD) related to the utility of its DecisionDx-SCC test in clinical decision-making regarding the use of ART.

The consensus guidelines outline a recommended risk-based workflow that integrates DecisionDx-SCC and AJCC8 staging into current National Comprehensive Cancer Network (NCCN) guidelines to improve precision in ART recommendations based on which patients are at the highest risk for metastasis and most likely to benefit from treatment.

'ART is recommended by evidence-based guidelines to reduce the risk of recurrence in patients with high-risk SCC,' said Ramesh Gopal, M.D., Ph.D., lead author, radiation oncologist and associate professor of radiation oncology at the New Mexico Comprehensive Cancer Center in Albuquerque, New Mexico. 'While the presence of perineural invasion (PNI) will typically trigger a conversation about whether to consider ART, the guidelines vary in their interpretation of which SCC patients should be considered for the treatment, which can carry a risk of side-effects for the patient and costs for our healthcare system.'

The expert panel convened in June 2023 to review validation and real-world data for the DecisionDx-SCC test and to discuss their experiences, rationales and scenarios in which they have used the test to improve risk stratification and more accurately identify SCC patients at high risk of metastasis who may benefit from ART. The panel identified gaps in current clinical practice where the DecisionDx-SCC test has utility in guiding treatment decisions, including its use regarding: Escalation of care for lower-stage patients with high-risk tumors, De-escalation of care for patients for whom the risks of ART may outweigh the benefits, and Decision-making regarding elective radiation to the nodal basin.

Based on these gaps, the panel developed risk-based clinical recommendations and a workflow for ART referral in patients with SCC, which can be viewed in the JCAD article. The workflow integrates DecisionDx-SCC testing, which analyzes a patient's tumor biology to independently predict risk of nodal or distant metastasis, and AJCC8 staging, which is based on a patient's clinicopathologic risk factors, into current NCCN guidelines with a goal of improving precision in ART recommendations in the SCC patient population.

'As a panel, we agreed that the process used today to route SCC patients for ART can be improved, and DecisionDx-SCC can be a determining factor in the next step for management of high-risk SCC,' added Gaurav Singh, M.D., MPH, consensus panel member, and board-certified dermatologist, Mohs surgeon and assistant professor of dermatology in Wisconsin. 'The test provides independent risk-stratification that can augment existing risk prediction systems, including AJCC8 and Brigham and Women's Hospital (BWH) staging, to inform these important decisions with greater accuracy and ensure ART is brought to patients with the highest risk of disease progression who are most likely to benefit from treatment. DecisionDx-SCC can also help validate the decision to avoid radiation in seemingly high-risk tumors that are in fact low risk based on genetic profile.'

Specific consensus recommendations and statements outlined in the article include the following: A DecisionDx-SCC Class 2A or 2B result, indicating a higher or highest risk of metastasis, in each AJCC8 tumor stage serves as a high- or very high-risk feature for consideration in recommending ART.

The increased metastatic risk conferred by a Class 2A or 2B result in multivariate analysis (hazard ratio=2.3, p=0.013 and hazard ratio=6.9, p

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