New Prospective, Multicenter Study Presented at SMR Demonstrates Castle Biosciences’ DecisionDx®-Melanoma Test Provides Significant Risk Prediction for Patients with Cutaneous Melanoma, Adding Value to Current Stage-Based Treatment Pathway Decisions
Castle Biosciences announced new data presentations for its DecisionDx-Melanoma and DecisionDx-UM tests at the 21st International Congress of the Society for Melanoma Research (SMR). A prospective, multicenter study of 876 patients with Stage I-III cutaneous melanoma showed that DecisionDx-Melanoma significantly stratified patients by recurrence risk and added prognostic value to AJCC staging. Patients with Class 1A results had higher three-year recurrence-free survival compared to Class 1B/2A or 2B (p<0.001).
The company will also present data on DecisionDx-UM for uveal melanoma, confirming PRAME status as a risk modifier. Castle Biosciences' CEO Derek Maetzold stated that their tests provide clinical value beyond current staging methods, enabling improved risk-aligned treatment decisions associated with better outcomes.
Castle Biosciences ha annunciato nuove presentazioni di dati per i suoi test DecisionDx-Melanoma e DecisionDx-UM al 21° Congresso Internazionale della Society for Melanoma Research (SMR). Uno studio multicentrico prospettico su 876 pazienti con melanoma cutaneo di stadio I-III ha dimostrato che DecisionDx-Melanoma stratifica significativamente i pazienti in base al rischio di recidiva e aggiunge valore prognostico alla stadiazione AJCC. I pazienti con risultati di Classe 1A hanno avuto una maggiore sopravvivenza libera da recidive a tre anni rispetto a Classe 1B/2A o 2B (p<0.001).
La compagnia presenterà anche dati su DecisionDx-UM per il melanoma uveale, confermando lo stato di PRAME come modificatore di rischio. Il CEO di Castle Biosciences, Derek Maetzold, ha dichiarato che i loro test offrono un valore clinico oltre ai metodi di stadiazione attuali, consentendo decisioni terapeutiche migliorate allineate al rischio associate a risultati migliori.
Castle Biosciences anunció nuevas presentaciones de datos para sus pruebas DecisionDx-Melanoma y DecisionDx-UM en el 21° Congreso Internacional de la Sociedad de Investigación sobre Melanoma (SMR). Un estudio multicéntrico prospectivo de 876 pacientes con melanoma cutáneo en estadio I-III mostró que DecisionDx-Melanoma estratificó significativamente a los pacientes según el riesgo de recurrencia y añadió valor pronóstico a la estadificación AJCC. Los pacientes con resultados de Clase 1A tuvieron una mayor supervivencia libre de recurrencias a tres años en comparación con Clase 1B/2A o 2B (p<0.001).
La compañía también presentará datos sobre DecisionDx-UM para el melanoma uveal, confirmando el estado de PRAME como un modificador de riesgo. El director ejecutivo de Castle Biosciences, Derek Maetzold, declaró que sus pruebas proporcionan un valor clínico más allá de los métodos de estadificación actuales, lo que permite decisiones de tratamiento alineadas con el riesgo, asociadas a mejores resultados.
Castle Biosciences는 제21회 세계 흑멜라종 연구 협회(SMR) 국제 대회에서 DecisionDx-Melanoma와 DecisionDx-UM 테스트에 대한 새로운 데이터 발표를 알렸습니다. 1-3기 피부 흑멜라종 환자 876명을 대상으로 한 다기관 전향적 연구에서 DecisionDx-Melanoma가 재발 위험에 따라 환자를 유의미하게 분류하고 AJCC 병기에도 예후적 가치를 더한 것으로 나타났습니다. 클래스 1A 결과를 가진 환자는 클래스 1B/2A 또는 2B와 비교하여 3년 생존율이 더 높았습니다(p<0.001).
회사는 PRAME 상태를 위험Modifier로 확인하며 DecisionDx-UM에 대한 데이터도 발표할 예정입니다. Castle Biosciences의 CEO인 Derek Maetzold는 그들의 테스트가 현재 병기 방법을 넘어서는 임상 가치를 제공하여 더 나은 결과와 연관된 위험 조정 치료 결정을 가능하게 한다고 밝혔습니다.
Castle Biosciences a annoncé de nouvelles présentations de données pour ses tests DecisionDx-Melanoma et DecisionDx-UM lors du 21e Congrès International de la Société de Recherche sur le Mélanome (SMR). Une étude prospective multicentrique portant sur 876 patients atteints de mélanome cutané de stade I-III a montré que DecisionDx-Melanoma stratifie significativement les patients par risque de récidive et ajoute une valeur pronostique à la stadification AJCC. Les patients avec des résultats de Classe 1A ont eu une survie sans récidive à trois ans supérieure à celle des Classes 1B/2A ou 2B (p<0.001).
L'entreprise présentera également des données sur DecisionDx-UM pour le mélanome uvéal, confirmant le statut PRAME en tant que modificateur de risque. Derek Maetzold, PDG de Castle Biosciences, a déclaré que leurs tests offrent une valeur clinique au-delà des méthodes de stadification actuellement utilisées, permettant des décisions de traitement mieux alignées sur le risque associées à de meilleurs résultats.
Castle Biosciences kündigte neue Datenpräsentationen für seine Tests DecisionDx-Melanoma und DecisionDx-UM auf dem 21. Internationalen Kongress der Society for Melanoma Research (SMR) an. Eine prospektive, multizentrische Studie mit 876 Patienten mit kutanem Melanom im Stadium I-III zeigte, dass DecisionDx-Melanoma die Patienten signifikant nach Rückfallrisiko stratifizierte und prognostischen Mehrwert für die AJCC-Staging hinzufügte. Patienten mit Ergebnissen der Klasse 1A hatten eine höhere dreijährige Rückfall-freie Überlebensrate im Vergleich zu Klasse 1B/2A oder 2B (p<0.001).
Das Unternehmen wird auch Daten zu DecisionDx-UM für uveales Melanom präsentieren, das den PRAME-Status als Risikomodifikator bestätigt. Derek Maetzold, CEO von Castle Biosciences, erklärte, dass ihre Tests klinischen Wert über die aktuellen Staging-Methoden hinaus bieten und verbesserte risikobasierte Behandlungsentscheidungen ermöglichen, die mit besseren Ergebnissen verbunden sind.
- DecisionDx-Melanoma test significantly stratified patients by recurrence risk in a large prospective study
- DecisionDx-Melanoma added prognostic value to AJCC staging
- Patients with Class 1A results showed higher three-year recurrence-free survival
- Study results support the clinical value of DecisionDx-Melanoma in improving treatment decisions
- None.
Insights
This study presents significant findings for Castle Biosciences' DecisionDx-Melanoma test, demonstrating its value in risk prediction for cutaneous melanoma patients. The prospective, multicenter study involving 876 patients with Stage I-III cutaneous melanoma showed that the test:
- Effectively stratified patients by recurrence risk
- Was a significant predictor of recurrence
- Added substantial predictive value to AJCC staging
Notably, patients with Class 1A (lowest risk) results had significantly higher three-year recurrence-free survival compared to those with Class 1B/2A (increased risk) or Class 2B (highest risk) results (p<0.001). This data suggests that integrating DecisionDx-Melanoma into clinical practice could lead to more personalized, risk-aligned treatment decisions, potentially improving patient outcomes.
For investors, this strengthens Castle Biosciences' position in the melanoma diagnostics market. The test's ability to provide additional prognostic information beyond current staging methods could drive increased adoption among oncologists, potentially boosting the company's revenue and market share in the growing field of precision oncology.
“In large prospective and retrospective studies, our DecisionDx-Melanoma test has been shown to provide clinical value above and beyond current staging paradigms and other tests currently available for patients with cutaneous melanoma,” said Derek Maetzold, president and chief executive officer of Castle Biosciences. “Clinical use studies have shown that clinicians act upon these results to improve risk-aligned treatment pathway decisions which are associated with improved outcomes.”
Details regarding Castle’s posters at SMR are included below. Posters will be available for viewing starting the evening of Thursday, Oct. 10, through the evening of Saturday, Oct. 12.
DecisionDx-Melanoma
- Poster title: In a prospective, multicenter study, the 31-GEP identified patients at increased risk of tumor recurrence and added significant prognostic value to AJCC staging
- Poster #: 40
- Summary: This study included 876 patients with Stage I-III CM from multiple centers who received DecisionDx-Melanoma testing as part of their clinical care. The data show DecisionDx-Melanoma stratified patients by their risk of recurrence and was a significant predictor of recurrence; patients with Class 1A (lowest risk) test results had significantly higher three-year recurrence-free survival than those with a Class 1B/2A (increased risk) or Class 2B (highest risk) test result (p<0.001). Importantly, the test added significant predictive value to American Joint Committee on Cancer (AJCC) staging, considered the standard of care in melanoma management. These findings provide evidence that use of the test with melanoma patients enables better risk-aligned care decisions, which have been shown to lead to improved patient outcomes.1,2
DecisionDx-UM
- Poster title: Confirmation of PRAME status as a risk modifier of 15-gene expression profile class in a large real-world population-based cohort of uveal melanoma patients
- Poster #: 134
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 June 30, 2024, DecisionDx-Melanoma has been ordered more than 173,000 times for patients diagnosed with cutaneous melanoma. Learn more at www.CastleBiosciences.com.
About DecisionDx-UM
DecisionDx-UM is Castle Biosciences’ 15-gene expression profile (GEP) test that uses an individual patient’s tumor biology to predict individual risk of metastasis in patients with uveal melanoma (UM). DecisionDx-UM is the standard of care in the management of newly diagnosed UM in the majority of ocular oncology practices in
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 family of innovative genomic tests to (i) provide clinical value above and beyond current staging paradigms and other tests currently available for patients with CM and (ii) enable better risk-aligned care decisions to lead to improved patient outcomes. The words “can,” “may” 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 shown in this study, including with respect to the discussion of DecisionDx-Melanoma and DecisionDx-UM 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 June 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.
- Bailey CN, Martin BJ, Petkov VI, et al. 31-Gene Expression Profile Testing in Cutaneous Melanoma and Survival Outcomes in a Population-Based Analysis: A SEER Collaboration. JCO Precis. Oncol. 2023; 7. doi: 10.1200/PO.23.00044
- Dhillon S, Duarte-Bateman D, Fowler G, et al. Routine imaging guided by a 31-gene expression profile assay results in earlier detection of melanoma with decreased metastatic tumor burden compared to patients without surveillance imaging studies. Arch Dermatol Res. 2023. https://doi.org/10.1007/s00403-023-02613-6.
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Investor Contact:
Camilla Zuckero
czuckero@castlebiosciences.com
Media Contact:
amarshall@castlebiosciences.com
Source: Castle Biosciences Inc.
FAQ
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