Independent Systematic Review and Meta-Analysis Attests to the Significant Risk Stratification Provided by Castle Biosciences’ DecisionDx®-Melanoma Test, Contributing to Personalized Management of Patients with Melanoma
Castle Biosciences (CSTL) announced the publication of an independent meta-analysis in Cancers evaluating their DecisionDx-Melanoma test for predicting melanoma patient outcomes. The analysis, reviewing 13 peer-reviewed studies, confirms the test's effectiveness in risk stratification for cutaneous melanoma (CM) patients.
The study revealed five-year melanoma-specific survival rates of 99.8% for lowest risk (Class 1A), 97.6% for increased risk (Class 1B/2A), and 83.4% for highest risk (Class 2B) patients. The test demonstrated consistent ability to stratify patients into risk groups with significantly different outcomes, supporting its use alongside current staging systems for enhanced patient care management.
Castle Biosciences (CSTL) ha annunciato la pubblicazione di una meta-analisi indipendente su Cancers che valuta il loro test DecisionDx-Melanoma per la previsione dei risultati nei pazienti affetti da melanoma. L'analisi, che rivede 13 studi sottoposti a peer review, conferma l'efficacia del test nella stratificazione del rischio per i pazienti con melanoma cutaneo (CM).
Lo studio ha rivelato tassi di sopravvivenza specifici per melanoma a cinque anni del 99.8% per il rischio più basso (Classe 1A), 97.6% per il rischio aumentato (Classe 1B/2A), e 83.4% per il rischio più alto (Classe 2B). Il test ha dimostrato una consistente capacità di stratificare i pazienti in gruppi di rischio con esiti significativamente differenti, supportando il suo utilizzo insieme ai sistemi di stadiazione attuali per una migliore gestione dell'assistenza ai pazienti.
Castle Biosciences (CSTL) anunció la publicación de un meta-análisis independiente en Cancers que evalúa su prueba DecisionDx-Melanoma para predecir los resultados en pacientes con melanoma. El análisis, que revisa 13 estudios revisados por pares, confirma la efectividad de la prueba en la estratificación del riesgo para pacientes con melanoma cutáneo (CM).
El estudio reveló tasas de supervivencia específicas para melanoma a cinco años de 99.8% para el riesgo más bajo (Clase 1A), 97.6% para el riesgo aumentado (Clase 1B/2A), y 83.4% para el riesgo más alto (Clase 2B). La prueba demostró una capacidad consistente para estratificar a los pacientes en grupos de riesgo con resultados significativamente diferentes, lo que apoya su uso junto con los sistemas de estadificación actuales para una mejor gestión de la atención al paciente.
캐슬 바이오사이언스(CSTL)는 멜라노마 환자의 결과 예측을 위한 그들의 DecisionDx-Melanoma 테스트에 대한 독립적인 메타 분석의 출판을 발표했습니다. 13개의 동료 검토 연구를 검토한 이 분석은 피부 멜라노마(CM) 환자에 대한 위험 계층화에서 테스트의 효과를 확인했습니다.
이 연구는 최저 위험(1A 클래스) 환자와의 5년 멜라노마 특이 생존율이 99.8%, 위험 증가(1B/2A 클래스) 환자는 97.6%, 최고 위험(2B 클래스) 환자는 83.4%임을 밝혀냈습니다. 이 테스트는 결과가 현저히 다른 위험 그룹으로 환자를 일관되게 계층화하는 능력을 입증하여, 현재의 병기 시스템과 함께 사용하여 환자 관리 향상을 지원합니다.
Castle Biosciences (CSTL) a annoncé la publication d'une méta-analyse indépendante dans Cancers évaluant leur test DecisionDx-Melanoma pour prédire les résultats chez les patients atteints de mélanome. L'analyse, qui examine 13 études évaluées par des pairs, confirme l'efficacité du test dans la stratification des risques pour les patients atteints de mélanome cutané (CM).
Etude a révélé des taux de survie spécifiques au mélanome sur cinq ans de 99.8% pour le risque le plus bas (Classe 1A), 97.6% pour le risque accru (Classe 1B/2A), et 83.4% pour le risque le plus élevé (Classe 2B). Le test a démontré une capacité cohérente à stratifier les patients en groupes de risque avec des résultats significativement différents, soutenant son utilisation conjointement avec les systèmes de stadification actuels pour améliorer la gestion des soins aux patients.
Castle Biosciences (CSTL) gab die Veröffentlichung einer unabhängigen Meta-Analyse in Cancers bekannt, die ihren DecisionDx-Melanoma-Test zur Vorhersage der Ergebnisse bei Melanomapatienten bewertet. Die Analyse, die 13 peer-reviewed Studien überprüft, bestätigt die Wirksamkeit des Tests bei der Risiko-Stratifizierung für Patienten mit kutanem Melanom (CM).
Die Studie ergab fünfjährige, melanoomspezifische Überlebensraten von 99.8% für das niedrigste Risiko (Klasse 1A), 97.6% für erhöhtes Risiko (Klasse 1B/2A) und 83.4% für das höchste Risiko (Klasse 2B) Patienten. Der Test zeigte eine konstante Fähigkeit, Patienten in Risikogruppen mit signifikant unterschiedlichen Ergebnissen zu stratifizieren, was die Verwendung zusammen mit den aktuellen Staging-Systemen zur Verbesserung des Patientenmanagements unterstützt.
- Meta-analysis of 13 peer-reviewed studies validates DecisionDx-Melanoma test's effectiveness
- Test shows high accuracy in predicting survival rates across different risk classes
- Demonstrates significant clinical utility in improving patient care strategies
- None.
Insights
This meta-analysis significantly validates DecisionDx-Melanoma's clinical utility in melanoma risk stratification. The test shows impressive predictive accuracy with
This independent validation strengthens Castle Biosciences' market position in the precision oncology diagnostics sector. With a market cap of
This recently published meta-analysis encompasses 13 peer-reviewed publications involving thousands of patients and affirms the powerful risk stratification provided by DecisionDx-Melanoma and its potential to significantly improve care for patients with cutaneous melanoma (CM)
“We believe the clinical performance of our DecisionDx-Melanoma test is unmatched by other tests currently on the market, both in its ability to provide precise and clinically meaningful risk stratification as well as accurate predictions of sentinel lymph node positivity,” said Matthew Goldberg, M.D., board-certified dermatologist and dermatopathologist, and senior vice president, medical, of Castle Biosciences. “This independent publication adds to the robust body of evidence supporting DecisionDx-Melanoma and provides a compelling analysis highlighting the broad utility of the test to improve care for patients with melanoma.”
The authors evaluated peer-reviewed articles that analyzed DecisionDx-Melanoma risk class data alongside at least one survival-based metric with a minimum of three years of follow-up. Systematic reviews, meta-analyses and studies without at least three years of patient follow-up were excluded. Following these criteria and additional analyses using Oxford Center guidelines and the Quality in Prognosis Studies (QUIPS) tool, which assesses six domains of bias, a total of 13 studies were included in the meta-analysis.
Across all studies, the DecisionDx-Melanoma test consistently stratified patients into risk groups with significantly different outcomes. The five-year melanoma-specific survival rates were:
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99.8% (95% CI: 98–100% ) for patients with a Class 1A/lowest risk test result, -
97.6% (95% CI: 92.4–99.3% ) for patients with a Class 1B/2A/increased risk test result and -
83.4% (95% CI: 66.5–92.7% ) for patients with a Class 2B/highest risk test result.
Similar trends were observed for recurrence-free and distant metastasis-free survival, showing a significant separation of risk between patients with Class 1A and Class 2B test results.
As summarized by the authors, “the ability to more accurately stratify patients based on their risk of recurrence and metastasis has the potential to significantly improve personalized care strategies, optimizing the balance between treatment efficacy and quality of life for patients with CM.” The findings provide further support for use of the DecisionDx-Melanoma test alongside current staging systems to enhance risk stratification and inform personalized management strategies for melanoma patients.
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: the ability of the DecisionDx-Melanoma test to (i) significantly improve care for patients with CM; (ii) consistently provide improved risk stratification over staging alone to inform personalized management strategies for patients with CM; and (iii) provide accurate predictions of sentinel lymph node positivity. 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, our Quarterly Report on Form 10-Q for the quarter ended September 30, 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. Durgham RA, Nassar SI, Gun R, et al. The Prognostic Value of the 31-Gene Expression Profile Test in Cutaneous Melanoma: A Systematic Review and Meta-Analysis. Cancers. 2024; 16(21):3714. https://doi.org/10.3390/cancers16213714
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Investor Contact:
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Source: Castle Biosciences Inc.
FAQ
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