Use of Castle Biosciences’ DecisionDx®-Melanoma Test Significantly Reduces Unnecessary SLNB Procedures, Latest Findings from Prospective, Multicenter DECIDE Study Presented at Dermato-Onco2024
Castle Biosciences presented new data from their DECIDE study showing that their DecisionDx-Melanoma test reduced unnecessary sentinel lymph node biopsy (SLNB) procedures by 25%. The study, presented at Dermato-Onco2024, included 471 patients with T1-T2a melanoma tumors. Among patients who underwent SLNB, none with low-risk DecisionDx-Melanoma results (predicted risk <5%) had positive nodes, while 9.8% of those with predicted risk ≥5% showed positive results. The test integrates tumor biology with clinicopathologic factors to predict SLN positivity risk, helping physicians and patients make informed decisions about SLNB procedures.
Castle Biosciences ha presentato nuovi dati dal loro studio DECIDE, dimostrando che il loro test DecisionDx-Melanoma ha ridotto le procedure non necessarie di biopsia dei linfonodi sentinella (SLNB) del 25%. Lo studio, presentato a Dermato-Onco2024, ha incluso 471 pazienti con tumori di melanoma T1-T2a. Tra i pazienti che hanno subito SLNB, nessuno con risultati di DecisionDx-Melanoma a basso rischio (rischio previsto <5%) aveva linfonodi positivi, mentre il 9,8% di coloro con rischio previsto ≥5% ha mostrato risultati positivi. Il test integra la biologia tumorale con fattori clinicopatologici per prevedere il rischio di positività del linfonodo sentinella, aiutando medici e pazienti a prendere decisioni informate riguardo le procedure SLNB.
Castle Biosciences presentó nuevos datos de su estudio DECIDE, mostrando que su prueba DecisionDx-Melanoma redujo los procedimientos innecesarios de biopsia de ganglio linfático centinela (SLNB) en un 25%. El estudio, presentado en Dermato-Onco2024, incluyó a 471 pacientes con tumores de melanoma T1-T2a. Entre los pacientes que se sometieron a SLNB, ninguno con resultados de DecisionDx-Melanoma de bajo riesgo (riesgo predicho <5%) tenía ganglios positivos, mientras que el 9.8% de aquellos con riesgo predicho ≥5% mostró resultados positivos. La prueba integra la biología tumoral con factores clinicopatológicos para predecir el riesgo de positividad de los ganglios linfáticos centinela, ayudando a médicos y pacientes a tomar decisiones informadas sobre los procedimientos de SLNB.
Castle Biosciences는 DECIDE 연구에서 새로운 데이터를 발표하면서 그들의 DecisionDx-Melanoma 테스트가 불필요한 감시 림프절 생검(SLNB) 절차를 25% 줄였다고 밝혔습니다. 이 연구는 Dermato-Onco2024에서 발표되었으며, T1-T2a 흑색종 종양을 가진 471명의 환자를 포함했습니다. SLNB를 받은 환자 중, 위험도가 낮은 DecisionDx-Melanoma 결과(예상 위험 <5%)를 가진 환자는 긍정적인 림프절이 없었고, 반면 위험도가 ≥5%로 예상된 환자의 9.8%가 긍정적인 결과를 보였습니다. 이 테스트는 종양 생물학과 임상 병리학적 요인을 통합하여 SLN 양성 위험을 예측하여 의사와 환자가 SLNB 절차에 대한 정보에 기반한 결정을 내릴 수 있도록 돕습니다.
Castle Biosciences a présenté de nouvelles données issues de leur étude DECIDE, montrant que leur test DecisionDx-Melanoma a réduit de 25% les procédures de biopsie des ganglions lymphatiques sentinelles (SLNB) non nécessaires. L'étude, présentée à Dermato-Onco2024, a inclus 471 patients avec des tumeurs de mélanome T1-T2a. Parmi les patients ayant subi une SLNB, aucun avec des résultats à faible risque de DecisionDx-Melanoma (risque prévu <5%) n'avait des ganglions positifs, tandis que 9,8 % de ceux avec un risque prédit ≥5 % ont montré des résultats positifs. Le test intègre la biologie tumorale avec des facteurs clinicopathologiques pour prédire le risque de positivité des ganglions lymphatiques sentinelles, aidant ainsi médecins et patients à prendre des décisions éclairées concernant les procédures de SLNB.
Castle Biosciences präsentierte neue Daten aus ihrer DECIDE-Studie, die zeigen, dass ihr DecisionDx-Melanoma-Test unnötige Verfahren zur Biopsie von Sentinel-Lymphknoten (SLNB) um 25% reduziert hat. Die Studie, die auf Dermato-Onco2024 präsentiert wurde, umfasste 471 Patienten mit T1-T2a Melanomtumoren. Unter den Patienten, die sich einer SLNB unterzogen, hatten keine mit niedrigen Risikoergebnissen von DecisionDx-Melanoma (vorhergesagtes Risiko <5%) positive Knoten, während 9,8% derjenigen, deren vorhergesagtes Risiko ≥5% betrug, positive Ergebnisse zeigten. Der Test integriert Tumorbiologie mit klinikopathologischen Faktoren, um das Risiko einer SLN-Positivität vorherzusagen und unterstützt Ärzte und Patienten dabei, informierte Entscheidungen über SLNB-Verfahren zu treffen.
- 25% reduction in unnecessary SLNB procedures
- 100% accuracy in predicting low-risk cases (0/58 patients)
- Test successfully identified high-risk cases with 9.8% positive SLN rate
- None.
Insights
The latest DECIDE study results demonstrate significant clinical value for Castle Biosciences' DecisionDx-Melanoma test. The 25% reduction in unnecessary SLNB procedures represents meaningful progress in patient care and cost efficiency. The test showed remarkable accuracy - zero false negatives in patients predicted to have <5% risk, validating its reliability as a decision-making tool.
Most importantly, the study included 471 patients with challenging tumor stages (T1a with high-risk features, T1b and T2a) where SLNB decisions are typically most difficult. The test successfully identified patients with ≥5% risk, showing 9.8% positivity rate in this group - aligning well with clinical expectations and NCCN guidelines.
This validation strengthens the test's clinical utility and potential for insurance coverage, as it demonstrates both improved patient care and cost savings by reducing unnecessary surgical procedures.
Study shows a
Among patients electing to have an SLNB, no positive nodes were identified among those with low-risk DecisionDx-Melanoma test results (i.e., predicted sentinel lymph node (SLN) positivity risk of less than
“We continue to share data from our DECIDE study highlighting the performance of the DecisionDx-Melanoma test in providing precise predictions of SLN positivity, earlier this year at SSO 2024 and now at Dermato-Onco2024, with close to
Details regarding Castle’s oral presentation at Dermato-Onco2024 are included below:
DecisionDx-Melanoma
- Title: Clinical use of the i31-GEP for SLNB for T1-T2a cutaneous melanoma significantly and safely reduces unnecessary procedures
- Presenting Author: J. Michael Guenther, M.D.
Study highlights
SLNB is an invasive surgical procedure used at the time of diagnosis to determine whether melanoma has spread to nearby lymph nodes. The procedure returns a surgical result that is negative for metastasis in approximately
Current National Comprehensive Cancer Network (NCCN) guidelines suggest foregoing SLNB when the likelihood of finding a positive SLN is less than
The study showed that integrating DecisionDx-Melanoma test results into SLNB decisions resulted in
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 Sept. 30, 2024, DecisionDx-Melanoma has been ordered approximately 183,000 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, psoriasis and related conditions. 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 accurately identify patients with a low risk of metastasis who can safely forego SLNB, thereby reducing unnecessary SNLB procedures; (ii) the ability of the DecisionDx-Melanoma test to increase confidence of clinicians in decisions made when discussing a possible SLNB procedure; and (iii) the ability of the DecisionDx-Melanoma test to identify patients with sufficient risk of nodal positivity to consider SLNB . 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, 2023 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. Society of Surgical Oncology SSO 2024 Annual Meeting. Ann Surg Oncol 31 (Suppl 1), 1–294 (2024). https://doi.org/10.1245/s10434-024-15179-y: view presentation
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Investor Contact:
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czuckero@castlebiosciences.com
Media Contact:
amarshall@castlebiosciences.com
Source: Castle Biosciences Inc.
FAQ
What was the reduction in SLNB procedures using Castle Biosciences' (CSTL) DecisionDx-Melanoma test?
How accurate was the DecisionDx-Melanoma test in identifying low-risk melanoma patients?
What was the positive SLN rate for high-risk patients identified by DecisionDx-Melanoma?
