Castle Biosciences' DecisionDx®-SCC Data Earns Top Five Abstract at NCCN 2025, Shows Significantly Enhanced Risk Stratification Beyond Current Staging Within NCCN Risk Groups
Castle Biosciences (CSTL) will present new validation data for its skin cancer tests at the NCCN 2025 Annual Conference. The company's DecisionDx-SCC test, earning a top-five abstract recognition, demonstrated enhanced risk stratification in a large cohort of 1,412 high-risk squamous cell carcinoma patients.
The study showed that combining DecisionDx-SCC with BWH staging significantly improved metastatic risk prediction within NCCN risk groups. Class 1 results indicated a nearly two-fold decrease in metastatic risk, while Class 2B showed more than a five-fold increase in risk for lower-stage NCCN High-Risk patients.
Additionally, new data for DecisionDx-Melanoma, tested in 6,892 patients with early-stage cutaneous melanoma, demonstrated the test's ability to predict mortality risk beyond traditional AJCC8 staging criteria. The study validated the test's effectiveness in identifying high-risk patients who might benefit from enhanced surveillance.
Castle Biosciences (CSTL) presenterà nuovi dati di validazione per i suoi test sul cancro della pelle alla Conferenza Annuale NCCN 2025. Il test DecisionDx-SCC dell'azienda, che ha ricevuto un riconoscimento tra i primi cinque abstract, ha dimostrato un miglioramento nella stratificazione del rischio in un ampio campione di 1.412 pazienti ad alto rischio di carcinoma squamoso.
Lo studio ha mostrato che combinare DecisionDx-SCC con la stadiazione BWH ha migliorato significativamente la previsione del rischio metastatico all'interno dei gruppi di rischio NCCN. I risultati della Classe 1 hanno indicato una riduzione quasi doppia del rischio metastatico, mentre la Classe 2B ha mostrato un aumento di oltre cinque volte del rischio per i pazienti NCCN ad alto rischio in stadi inferiori.
Inoltre, nuovi dati per DecisionDx-Melanoma, testato su 6.892 pazienti con melanoma cutaneo in fase iniziale, hanno dimostrato la capacità del test di prevedere il rischio di mortalità oltre i criteri di stadiazione tradizionali AJCC8. Lo studio ha convalidato l'efficacia del test nell'identificare pazienti ad alto rischio che potrebbero beneficiare di un monitoraggio potenziato.
Castle Biosciences (CSTL) presentará nuevos datos de validación para sus pruebas de cáncer de piel en la Conferencia Anual NCCN 2025. La prueba DecisionDx-SCC de la compañía, que recibió un reconocimiento entre los cinco mejores resúmenes, demostró una mejor estratificación del riesgo en una amplia cohorte de 1,412 pacientes con carcinoma de células escamosas de alto riesgo.
El estudio mostró que combinar DecisionDx-SCC con la estadificación BWH mejoró significativamente la predicción del riesgo metastásico dentro de los grupos de riesgo de NCCN. Los resultados de la Clase 1 indicaron una disminución de casi el doble en el riesgo metastásico, mientras que la Clase 2B mostró un aumento de más de cinco veces en el riesgo para pacientes de alto riesgo de NCCN en etapas más bajas.
Además, nuevos datos para DecisionDx-Melanoma, probado en 6,892 pacientes con melanoma cutáneo en etapa temprana, demostraron la capacidad de la prueba para predecir el riesgo de mortalidad más allá de los criterios de estadificación tradicionales AJCC8. El estudio validó la efectividad de la prueba para identificar pacientes de alto riesgo que podrían beneficiarse de una vigilancia mejorada.
캐슬 바이오사이언스(CSTL)는 NCCN 2025 연례 회의에서 피부암 검사에 대한 새로운 검증 데이터를 발표할 예정입니다. 회사의 DecisionDx-SCC 테스트는 상위 5개 초록 인정을 받았으며, 1,412명의 고위험 편평세포암 환자 대규모 집단에서 위험 분류를 향상시켰습니다.
연구에 따르면 DecisionDx-SCC와 BWH 병기화를 결합하면 NCCN 위험 그룹 내에서 전이 위험 예측이 크게 향상되었습니다. 클래스 1 결과는 전이 위험이 거의 두 배 감소했음을 나타냈고, 클래스 2B는 낮은 단계의 NCCN 고위험 환자에 대해 5배 이상의 위험 증가를 보였습니다.
또한, 초기 단계 피부 흑색종 환자 6,892명을 대상으로 테스트된 DecisionDx-Melanoma의 새로운 데이터는 전통적인 AJCC8 병기 기준을 넘어 사망 위험을 예측하는 능력을 입증했습니다. 이 연구는 고위험 환자를 식별하는 데 있어 테스트의 효과를 검증하여 강화된 감시의 혜택을 받을 수 있는 환자를 찾는 데 기여했습니다.
Castle Biosciences (CSTL) présentera de nouvelles données de validation pour ses tests de cancer de la peau lors de la Conférence Annuelle NCCN 2025. Le test DecisionDx-SCC de l'entreprise, qui a reçu une reconnaissance parmi les cinq meilleurs résumés, a démontré une meilleure stratification des risques dans une large cohorte de 1 412 patients à haut risque de carcinome épidermoïde.
L'étude a montré que la combinaison de DecisionDx-SCC avec le stade BWH améliorait considérablement la prédiction du risque de métastases au sein des groupes de risque NCCN. Les résultats de la Classe 1 indiquaient une diminution presque double du risque de métastases, tandis que la Classe 2B montrait une augmentation de plus de cinq fois du risque pour les patients à haut risque de NCCN à des stades inférieurs.
De plus, de nouvelles données pour DecisionDx-Mélanome, testées chez 6 892 patients atteints de mélanome cutané à un stade précoce, ont démontré la capacité du test à prédire le risque de mortalité au-delà des critères de stadification traditionnels AJCC8. L'étude a validé l'efficacité du test pour identifier les patients à haut risque qui pourraient bénéficier d'une surveillance renforcée.
Castle Biosciences (CSTL) wird auf der NCCN-Jahreskonferenz 2025 neue Validierungsdaten für seine Hautkrebs-Tests vorstellen. Der DecisionDx-SCC-Test des Unternehmens, der eine Anerkennung unter den fünf besten Abstracts erhielt, zeigte eine verbesserte Risikostratifizierung in einer großen Kohorte von 1.412 Hochrisiko-Patienten mit Plattenepithelkarzinom.
Die Studie zeigte, dass die Kombination von DecisionDx-SCC mit der BWH-Stadienbestimmung das Risiko für Metastasen innerhalb der NCCN-Risikogruppen erheblich verbesserte. Die Ergebnisse der Klasse 1 wiesen auf eine fast doppelte Verringerung des metastatischen Risikos hin, während die Klasse 2B ein mehr als fünfmal höheres Risiko für NCCN-Hochrisiko-Patienten in niedrigeren Stadien zeigte.
Darüber hinaus zeigten neue Daten für DecisionDx-Melanoma, das bei 6.892 Patienten mit frühem kutanem Melanom getestet wurde, die Fähigkeit des Tests, das Sterberisiko über die traditionellen AJCC8-Stadienkriterien hinaus vorherzusagen. Die Studie validierte die Wirksamkeit des Tests zur Identifizierung von Hochrisikopatienten, die von einer intensiveren Überwachung profitieren könnten.
- DecisionDx-SCC test earned top-five abstract recognition at NCCN 2025
- Large validation cohort of 1,412 patients demonstrates significant improvement in risk prediction
- DecisionDx-Melanoma validated in substantial real-world study of 6,892 patients
- Both tests show enhanced risk stratification capabilities beyond current staging methods
- None.
Insights
Castle Biosciences' new validation data for their skin cancer tests represents significant clinical progress with potential revenue implications. The DecisionDx-SCC test's recognition as a top five abstract at NCCN 2025 is a notable achievement that increases visibility among oncologists and dermatologists who follow these influential guidelines.
The large validation cohort of 1,412 patients with high-risk squamous cell carcinoma provides robust evidence that DecisionDx-SCC significantly enhances metastatic risk stratification beyond current staging methods (p < 0.001). Particularly impressive is the test's ability to identify a nearly two-fold decrease in metastatic risk for Class 1 (low risk) patients and more than five-fold increase for Class 2B (highest risk) patients within the NCCN High-Risk category.
For DecisionDx-Melanoma, the real-world evidence study with 6,892 patients demonstrates the test's ability to identify higher mortality risk in patients classified as low-risk by conventional staging alone. This can directly influence treatment decisions, potentially justifying more comprehensive surveillance and management strategies for identified high-risk patients.
Both studies validate these tests as independent, statistically significant predictors that refine current staging systems. The publication in JNCCN further amplifies the scientific credibility of these findings. This clinical validation strengthens Castle's position in discussions with clinicians and payers, potentially accelerating adoption and improving reimbursement coverage - key drivers for diagnostic test commercial success.
New, combined validation cohort of 1,412 patients with high-risk squamous cell carcinoma (SCC) demonstrates that the addition of DecisionDx-SCC to Brigham & Women's Hospital (BWH) staging significantly refines metastatic risk prediction in patients classified as High-Risk and Very High-Risk by National Comprehensive Cancer Network (NCCN) guidelines to support improved, risk-aligned treatment pathway decisions
Castle will also present new data showing DecisionDx®-Melanoma as a significant predictor of mortality in a real-world cohort of nearly 7,000 patients with early-stage cutaneous melanoma (CM), reinforcing its value in identifying patients who may benefit from treatment plan strategies to improve outcomes
FRIENDSWOOD, Texas, March 28, 2025 (GLOBE NEWSWIRE) -- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, will share new data on its risk-stratification tests for patients with skin cancers, DecisionDx-SCC and DecisionDx-Melanoma, via two poster presentations at the NCCN 2025 Annual Conference, being held March 28-30 in Orlando, Florida. As a top five, blue-ribbon abstract at the conference, Castle’s poster on DecisionDx-SCC will also be shared in a special oral presentation with the other top-scoring submissions.
"Our latest data at NCCN highlight the significant prognostic capabilities of DecisionDx-SCC and DecisionDx-Melanoma, demonstrating their ability to enhance risk stratification beyond traditional staging,” said Rebecca Critchley-Thorne, Ph.D., vice-president, research and development, of Castle Biosciences. “By providing critical insights into predicted metastatic risk and survival likelihood, these tests equip clinicians with actionable results to enable more precise, personalized treatment decisions that may help optimize patient management and care.”
Castle’s posters will be available for viewing during the general poster sessions on March 28. As a top-scoring submission, Castle’s DecisionDx-SCC abstract will also be published in the print version of the JNCCN—Journal of the National Comprehensive Cancer Network. Additional details are included below:
DecisionDx-SCC
- Poster 5: Metastasis-free Survival Prediction with the 40-gene Expression Profile Test in Patients with Cutaneous Squamous Cell Carcinoma Risk Stratified According to the National Comprehensive Cancer Network Guidelines®
- Oral Poster Presentation: Friday, March 28, 3:45-5 p.m. Eastern Time
- Session: Oral Presentations from Top Poster Presenters and NCCN Foundation Young Investigator Awardees
- Presenter and Study Author: Shlomo A. Koyfman, M.D., director of the precision oncology program and director of head and neck radiotherapy at the Taussig Cancer Institute, Cleveland Clinic, Cleveland
Study highlights: This study assessed how integrating the DecisionDx-SCC test with BWH staging within NCCN guidelines can improve prognostic accuracy. An analysis of a new, combined multi-center cohort of 1,412 high-risk SCC patients, with one or more NCCN High-Risk or Very-High-Risk factors, showed that DecisionDx-SCC significantly enhanced metastatic risk stratification in NCCN High- and Very-High-Risk patient populations (p < 0.001). The test significantly improved BWH staging’s risk prediction accuracy (p < 0.001). Compared to the broader NCCN risk stratification, when DecisionDx-SCC was combined with BWH staging, Class 1 (low risk) test results showed a nearly two-fold decrease in metastatic risk and Class 2B (highest risk) results showed more than a five-fold increase in risk in lower-stage (BWH T1/T2a) NCCN High-Risk patients. These findings show that DecisionDx-SCC can significantly refine risk assessment when used with established staging methods, enabling more accurate, personalized treatment decisions based on a patient’s predicted metastatic risk.
DecisionDx-Melanoma
- Poster 31: The 31-GEP stratifies risk of death in patients with stage I-IIA cutaneous melanoma: A SEER real-world evidence study
- Lead Author: Harrison Nguyen, M.D., MBA, MPH, Houston Skin, Houston
Study highlights: This poster, part of Castle’s ongoing collaboration with the National Cancer Institute’s Surveillance, Epidemiology and End Results (SEER) Program Registries, presents new validation of the DecisionDx-Melanoma test’s risk-stratification performance in patients with thin/early-stage CM tumors (stage I-IIA). In a large, unselected real-world cohort of 6,892 patients classified as low risk by the American Joint Committee on Cancer Eighth Edition (AJCC8) staging system, the test identified individuals at higher risk of death. In multivariable analysis that included key AJCC8 staging criteria such as tumor thickness and ulceration as well as age and mitotic rate, the data demonstrated that the DecisionDx-Melanoma test is a significant predictor of both melanoma-specific and overall mortality. These findings highlight the test’s significant, independent risk-stratification capabilities, helping to identify patients at greater risk than indicated by AJCC8 staging alone who may benefit from enhanced surveillance and management to improve outcomes.
All abstracts at the conference will be published online at JNCCN.org.
About DecisionDx-SCC
DecisionDx-SCC is a 40-gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous squamous cell carcinoma metastasis for patients with one or more risk factors. The test result, in which patients are stratified into a Class 1 (low), Class 2A (higher) or Class 2B (highest) risk category, predicts individual metastatic risk to inform risk-appropriate management. Peer-reviewed publications have demonstrated that DecisionDx-SCC is an independent predictor of metastatic risk and that integrating DecisionDx-SCC with current prognostic methods can add positive predictive value to clinician decisions regarding staging and management. Learn more at www.CastleBiosciences.com.
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 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: the ability of DecisionDx-SCC to support improved, risk-aligned treatment pathway decisions; 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-SCC and DecisionDx-Melanoma and their ability to (i) enhance risk stratification beyond traditional staging and (ii) equip clinicians with actionable results to enable more precise, personalized treatment decisions and optimize patient management and care. 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.
Investor Contact:
Camilla Zuckero
czuckero@castlebiosciences.com
Media Contact:
Allison Marshall
amarshall@castlebiosciences.com
Source: Castle Biosciences, Inc.
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