Publication of Data from Prospective, Multicenter Study Demonstrates Positive Survival Outcomes in Patients with Low-Risk Melanoma Who Avoided Sentinel Lymph Node Biopsy with Information from Castle Biosciences' DecisionDx®-Melanoma Test

Consistent with prior studies, published results from Castle's DECIDE study show DecisionDx-Melanoma can both accurately identify patients with less than 5% risk of sentinel lymph node (SLN) positivity, who can safely consider forgoing the sentinel lymph node biopsy (SLNB) surgical procedure, and who are also unlikely to experience disease progression^1,2

As of the last follow-up, all of the patients in the third study analysis with a low-risk DecisionDx-Melanoma test result (Class 1A) were recurrence free, regardless of SLN status³

FRIENDSWOOD, Texas, April 03, 2025 (GLOBE NEWSWIRE) -- Castle Biosciences, Inc. (NASDAQ:CSTL), a company improving health through innovative tests that guide patient care, today announced the recent publication of two papers in the World Journal of Surgical Oncology and Cancer Medicine sharing reports from the prospective, multicenter DECIDE study demonstrating the significant impact of the Company's DecisionDx-Melanoma test on SLNB decision-making for patients with melanoma.^3,4

SLNB is a surgical procedure commonly used to determine whether a patient's melanoma has spread to nearby lymph nodes. While useful in the prognosis of patients for whom cancer is found in the lymph nodes, SLNB returns a surgical result that is negative for metastasis in approximately 88% of patients who undergo the procedure.⁵ Current National Comprehensive Cancer Network^® (NCCN) guidelines suggest forgoing SLNB when the likelihood of finding a positive SLN is less than 5%, considering SLNB when the risk is between 5-10% and offering the surgery when the likelihood of positivity is above 10%. Castle's prospective, multicenter DECIDE study was designed to assess the performance of the DecisionDx-Melanoma test in guiding SLNB decisions in patients with T1-T2 tumors and following these patients' long-term outcomes.

"Decision-making for patients whose staging-based risk falls within or around the 5-10% threshold (i.e., patients with T1-T2 tumors) can be challenging. Our study findings underscore the strength of the DecisionDx-Melanoma test to accurately identify patients with T1-T2 tumors who have a low risk of metastasis and can safely forgo SLNB, within guideline recommendations, without experiencing a melanoma recurrence," said J. Michael Guenther, M.D., lead study author and surgeon at St. Elizabeth Physicians in Edgewood, Kentucky. "As evidenced by the study data, use of the test's results can significantly reduce unnecessary SLNB procedures while decreasing complication rates and reducing costs associated with the procedure. This test helps enable clinicians to focus surgical procedures on patients more likely to have a positive node."

The initial report from DECIDE, published in 2023, showed that DecisionDx-Melanoma test results influenced 85% of SLNB decisions, demonstrating the significant clinical value of the test to help guide risk-aligned patient care.²

The second report, recently published in the World Journal of Surgical Oncology, confirmed the performance of a low-risk DecisionDx-Melanoma result to predict SLN positivity rates of less than 5% in patients who elected to have an SLNB despite the test result. In the second report, no patient with a DecisionDx-Melanoma-predicted risk of SLN positivity of less than 5% who decided to have an SLNB procedure had a positive node (0/35 patients).⁴

The third report, published in Cancer Medicine, shares outcomes of patients in the DECIDE study with a low-risk DecisionDx-Melanoma test result (Class 1A), of which approximately half (51.5%) decided to forgo an SLNB and 48.5% proceeded with an SLNB despite the DecisionDx-Melanoma test result. Of clinical significance, all patients with a low-risk Class 1A test result were recurrence free (100% recurrence free survival, median follow-up = two years).³

"DecisionDx-Melanoma helps empower patients and clinicians to make more informed, risk-aligned decisions about whether to safely forgo or pursue an SLNB based on the patient's personal risk of SLN positivity," continued Guenther. "Importantly, decisions to forgo the procedure can be made with confidence when guided by a low-risk DecisionDx-Melanoma test result."

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 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 December 31, 2024, DecisionDx-Melanoma has been ordered approximately 191,800 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 these and 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, i31-SLNB, i31-ROR, 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: (i) the ability of the DecisionDx-Melanoma test to (a) accurately identify patients with less than 5% risk of SLN positivity, who can safely consider forgoing the SLNB surgical procedure, and who are also unlikely to experience disease progression, (b) significantly reduce unnecessary SLNB procedures while decreasing complication rates and reducing costs associated with the procedure and (c) enable clinicians to focus surgical procedures on patients more likely to have a positive node; and (ii) DecisionDx-Melanoma's significant clinical value of the test to help guide risk-aligned patient care. The words "believe," "can," "could," "potential" 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.

1. Yamamoto M, Sickle-Santanello B, Beard T, et al. The 31-gene expression profile test informs sentinel lymph node biopsy decisions in patients with cutaneous melanoma: results of a prospective, multicenter study. Curr Med Res Opin. 2023;39(3):417-423. doi:10.1080/03007995.2023.2165813
2. Kriza C, Martin B, Bailey CN, Bennett J. Integrating the melanoma 31-gene expression profile test with clinical and pathologic features can provide personalized precision estimates for sentinel lymph node positivity: an independent performance cohort. World J Surg Oncol. 2024;22(1):228. doi:10.1186/s12957-024-03512-4
3. Guenther JM, Ward A, Martin BJ, et al. A Prospective, Multicenter Analysis of Recurrence-Free Survival After Sentinel Lymph Node Biopsy Decisions Influenced by the 31-GEP. Cancer Med. 2025;14(7):e70839. doi:10.1002/cam4.70839
4. Guenther JM, Ward A, Martin B, et al. A prospective, multicenter analysis of the integrated 31-gene expression profile test for sentinel lymph node biopsy (i31-GEP for SLNB) test demonstrates reduced number of unnecessary SLNBs in patients with cutaneous melanoma. World J Surg Oncol. 2025 Jan 3;23(1):5. doi: 10.1186/s12957-024-03640-x
5. Chen J, Xu Y, Wang Y, et al. Prognostic role of sentinel lymph node biopsy for patients with cutaneous melanoma: A retrospective study of surveillance, epidemiology, and end-result population-based data. Oncotarget. 2016;7(29):45671-45677. doi:10.18632/oncotarget.10140
   
   

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Source: Castle Biosciences Inc.