• Two posters will share data on the significant risk stratification provided by DecisionDx-Melanoma in a real-world cohort of patients with stage IIB-IIC cutaneous melanoma (CM) to help guide adjuvant therapy, and the role of the test in prompting use of imaging surveillance in early-stage patients at high risk of metastasis to the central nervous system (CNS)

FRIENDSWOOD, Texas, April 01, 2025 (GLOBE NEWSWIRE) -- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, will share data via two poster presentations at the 11^th World Congress of Melanoma and 21^st European Association of Dermato-Oncology (EADO) Congress, being held April 3-5, 2025, in Athens, Greece. The posters demonstrate the ability of the DecisionDx-Melanoma test to guide more informed, risk-aligned management decisions through the precise risk-stratification of patients with melanoma.

"The findings being presented at EADO demonstrate that DecisionDx-Melanoma provides valuable biological insights that complement traditional staging and may help clinicians tailor surveillance and treatment plans based on a patient's individual predicted risk of metastasis,” said Brent Moody, M.D., dermatologist and Mohs micrographic surgeon at Heritage Medical Associates in Nashville, Tennessee. “By better identifying which patients may benefit from intensified monitoring and adjuvant therapy, the test has the potential to significantly improve melanoma outcomes through more personalized care directed to those who need it most."

Castle will present the following posters at EADO. The corresponding abstracts can be found in the digital Book of Abstracts available for download on the EADO website.

DecisionDx-Melanoma

• Poster P5-30: Improved prognostic guidance with 31-gene expression profiling for patients with stage IIB-IIC cutaneous melanoma: a SEER collaboration
• Abstract: A-314
• Lead Author: Brent Moody, M.D., Heritage Medical Associates
• Key takeaways: In the study, DecisionDx-Melanoma effectively stratified melanoma-specific survival and overall survival in a real-world population of clinically tested patients with stage IIb-IIC CM (p<0.001). As demonstrated by the data, stage IIB-IIC patients with a DecisionDx-Melanoma Class 2B (high risk) result are at a significantly higher risk of death and may benefit from increased management such as adjuvant therapy and surveillance imaging.

• Poster P5-22: The 31-GEP identifies patients with localized cutaneous melanoma at the highest risk of metastasis to the central nervous system
• Abstract: A-270
• Lead Author: Merve Hasanov, M.D., oncologist and director of the division of medical oncology at The Ohio State University Comprehensive Cancer Center, Columbus, Ohio
• Key takeaways: This study demonstrates that the DecisionDx-Melanoma test can identify patients with earlier-stage melanoma who have a higher risk of CNS metastasis within the first three years post-diagnosis and who may benefit from more frequent imaging surveillance designed to identify metastases earlier and potentially improve patient survival. In the study, a Class 2B (high risk) DecisionDx-Melanoma test result was the only significant predictor of CNS metastasis in multivariable analyses that included clinicopathologic-based risk factors considered in the American Joint Committee on Cancer Eight Edition (AJCC8) staging (HR (95% CI) 9.21 (2.72-31.19); p<0.001).

To learn more about DecisionDx-Melanoma and how the test may help to improve care and outcomes for patients with melanoma, visit Castle’s booth and attend the product theater detailed below:

DecisionDx-Melanoma: Gene Expression Profile Testing to Guide Management Decisions for Patients with Cutaneous Melanoma

• Date and Time: Thursday, April 3, 16:45 – 17:45 local time
• Location: Mitropoulos Hall
• Presenter: John T. Vetto, M.D., FACS, FASA, renowned surgical oncologist and professor of surgery and dermatology at Oregon Health and Science University’s School of Medicine, Portland, Oregon

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 50 peer-reviewed and published studies, providing confidence in disease management plans that incorporate the test’s results. Through Dec. 31, 2024, DecisionDx-Melanoma has been ordered more than 191,000 times for patients diagnosed with cutaneous melanoma. Learn more at www.CastleBiosciences.com.

About Castle Biosciences

Castle Biosciences (Nasdaq: CSTL) is a leading diagnostics company improving health through innovative tests that guide patient care. The Company aims to transform disease management by keeping people first: patients, clinicians, employees and investors.

Castle’s current portfolio consists of tests for skin cancers, Barrett’s esophagus, mental health conditions and uveal melanoma. Additionally, the Company has active research and development programs for tests in other diseases with high clinical need, including its test in development to help guide systemic therapy selection for patients with moderate-to-severe atopic dermatitis seeking biologic treatment. To learn more, please visit www.CastleBiosciences.com and connect with us on LinkedIn, Facebook, X and Instagram. 

DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-SCC, MyPath Melanoma, DiffDx-Melanoma, TissueCypher, IDgenetix, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq are trademarks of Castle Biosciences, Inc.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. These forward-looking statements include, but are not limited to, statements concerning: the ability of the DecisionDx-Melanoma test to guide more informed, risk-aligned management decisions through the precise risk-stratification of patients with melanoma; DecisionDx-Melanoma’s value in identifying CM patients who may benefit from enhanced surveillance and management strategies to improve outcomes; and the significant prognostic capabilities of DecisionDx-Melanoma and its ability to (i) enhance risk stratification beyond traditional AJCC8 staging, (ii) equip clinicians with actionable results to enable more precise, personalized treatment decisions and optimize patient management and care and (iii) identify patients with earlier-stage melanoma who have a higher risk of CNS metastasis within the first three years post-diagnosis and who may benefit from more frequent imaging surveillance designed to identify metastases earlier and potentially improve patient survival. The words “believe,” “can” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation: subsequent study or trial results and findings may contradict earlier study or trial results and findings or may not support the results obtained in these studies, including with respect to the discussion of our tests in this press release; actual application of our tests may not provide the aforementioned benefits to patients; and the risks set forth under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024, and in our other filings with the SEC. The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements, except as may be required by law.

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