FDA Grants Breakthrough Device Designation to Castle Biosciences’ DecisionDx®-Melanoma Test
Castle Biosciences (Nasdaq: CSTL) has achieved a significant regulatory milestone as its DecisionDx-Melanoma test received Breakthrough Device designation from the FDA. The test is a gene expression profile (GEP) test designed for patients with stage I-III cutaneous melanoma, providing personalized risk assessment for metastasis and sentinel lymph node positivity.
The designation, granted to devices offering improved treatment or diagnosis of life-threatening conditions, is expected to accelerate the development and review process. Castle Biosciences plans to submit a device marketing submission to the FDA, aiming to expand access to this diagnostic tool that guides risk-aligned management decisions for melanoma patients.
Castle Biosciences (Nasdaq: CSTL) ha raggiunto un importante traguardo regolatorio: il suo test DecisionDx-Melanoma ha ottenuto la designazione di Dispositivo Innovativo (Breakthrough Device) dalla FDA. Questo test, basato sul profilo di espressione genica (GEP), è destinato a pazienti con melanoma cutaneo in stadio I-III e offre una valutazione personalizzata del rischio di metastasi e positività dei linfonodi sentinella.
La designazione, riservata a dispositivi che migliorano il trattamento o la diagnosi di condizioni potenzialmente letali, dovrebbe accelerare il processo di sviluppo e revisione. Castle Biosciences prevede di presentare una domanda di commercializzazione del dispositivo alla FDA, con l’obiettivo di ampliare l’accesso a questo strumento diagnostico che supporta decisioni di gestione del melanoma basate sul rischio.
Castle Biosciences (Nasdaq: CSTL) ha alcanzado un hito regulatorio importante al recibir la designación de Dispositivo Innovador (Breakthrough Device) por parte de la FDA para su test DecisionDx-Melanoma. Esta prueba, basada en el perfil de expresión génica (GEP), está diseñada para pacientes con melanoma cutáneo en estadio I-III y proporciona una evaluación personalizada del riesgo de metástasis y positividad en los ganglios linfáticos centinela.
La designación, otorgada a dispositivos que ofrecen mejoras en el tratamiento o diagnóstico de condiciones potencialmente mortales, se espera que acelere el proceso de desarrollo y revisión. Castle Biosciences planea presentar una solicitud de comercialización a la FDA para ampliar el acceso a esta herramienta diagnóstica que orienta las decisiones de manejo alineadas con el riesgo en pacientes con melanoma.
Castle Biosciences (나스닥: CSTL)는 FDA로부터 DecisionDx-Melanoma 검사에 대해 획기적 의료기기(Breakthrough Device) 지정을 받아 중요한 규제 성과를 달성했습니다. 이 검사는 1~3기 피부 흑색종 환자를 위한 유전자 발현 프로필(GEP) 검사로, 전이 및 감시림프절 양성 여부에 대한 맞춤형 위험 평가를 제공합니다.
생명을 위협하는 질환의 치료 또는 진단을 개선하는 기기에 부여되는 이 지정은 개발 및 심사 과정을 가속화할 것으로 기대됩니다. Castle Biosciences는 이 진단 도구의 접근성을 확대하기 위해 FDA에 의료기기 마케팅 신청서를 제출할 계획이며, 이는 흑색종 환자의 위험에 맞춘 관리 결정을 지원합니다.
Castle Biosciences (Nasdaq : CSTL) a franchi une étape réglementaire importante avec la désignation de son test DecisionDx-Melanoma comme dispositif révolutionnaire (Breakthrough Device) par la FDA. Ce test, basé sur le profil d'expression génique (GEP), est destiné aux patients atteints de mélanome cutané de stade I à III et fournit une évaluation personnalisée du risque de métastases et de positivité des ganglions sentinelles.
Cette désignation, accordée aux dispositifs offrant une amélioration dans le traitement ou le diagnostic de maladies potentiellement mortelles, devrait accélérer le processus de développement et d'examen. Castle Biosciences prévoit de soumettre une demande de mise sur le marché à la FDA afin d'élargir l'accès à cet outil diagnostique qui guide les décisions de gestion du mélanome en fonction du risque.
Castle Biosciences (Nasdaq: CSTL) hat einen wichtigen regulatorischen Meilenstein erreicht, da der DecisionDx-Melanoma-Test von der FDA die Breakthrough Device-Zulassung erhalten hat. Der Test ist ein Genexpressionsprofil (GEP)-Test, der für Patienten mit kutanem Melanom im Stadium I-III entwickelt wurde und eine personalisierte Risikobewertung für Metastasen und Sentinel-Lymphknoten-Positivität bietet.
Die Zulassung, die Geräten gewährt wird, die eine verbesserte Behandlung oder Diagnose lebensbedrohlicher Erkrankungen ermöglichen, soll den Entwicklungs- und Prüfungsprozess beschleunigen. Castle Biosciences plant, eine Zulassungsanmeldung bei der FDA einzureichen, um den Zugang zu diesem diagnostischen Instrument zu erweitern, das risikoorientierte Managemententscheidungen für Melanompatienten unterstützt.
- FDA Breakthrough Device designation received for DecisionDx-Melanoma test
- Accelerated regulatory pathway through FDA's Breakthrough Devices Program
- Test provides unique biological insights for personalized melanoma care
- Superior clinical performance claimed compared to other market alternatives
- FDA marketing submission still pending and approval not guaranteed
- Timeline for potential FDA approval remains uncertain
Insights
FDA Breakthrough Device designation for Castle's melanoma test accelerates regulatory pathway and enhances market positioning against competitors.
The FDA's Breakthrough Device designation for Castle Biosciences' DecisionDx-Melanoma test represents a significant regulatory milestone with substantial implications. This designation is selectively granted to devices showing potential for improved treatment or diagnosis of life-threatening conditions compared to existing alternatives. For
What makes this particularly valuable is the test's differentiated position in melanoma diagnostics. The DecisionDx-Melanoma test employs gene expression profiling to stratify melanoma patients based on metastasis risk and predict sentinel lymph node positivity - critical factors in treatment planning for stage I-III cutaneous melanoma. The company explicitly states their test provides "precise and clinically meaningful risk stratification" that is "unmatched by other tests currently on the market" - suggesting a competitive advantage in the precision oncology space.
The regulatory implications are substantial. This designation accelerates the pathway toward potential FDA marketing authorization, which would transition the test from laboratory-developed test (LDT) status to an FDA-cleared/approved diagnostic. This regulatory upgrade typically enhances adoption, reimbursement potential, and market positioning. Castle's statement that they "expect to submit a device marketing submission" indicates they're actively pursuing this formal FDA clearance/approval process, which could significantly expand market access and clinical integration if successful.
FRIENDSWOOD, Texas, July 23, 2025 (GLOBE NEWSWIRE) -- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced that its DecisionDx-Melanoma test has been granted Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). DecisionDx-Melanoma is a gene expression profile (GEP) test that provides comprehensive, personalized results to guide risk-aligned management decisions for patients diagnosed with stage I-III cutaneous melanoma.
“DecisionDx-Melanoma provides valuable biological insights that help inform clinicians’ post-diagnosis decision making based on a patient's individual predicted risk of metastasis,” said Derek Maetzold, president and chief executive officer of Castle Biosciences. “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.
“We believe this recognition by the FDA supports DecisionDx-Melanoma's potential to significantly improve melanoma outcomes by delivering personalized care to those who need it most. We expect to submit a device marketing submission to the FDA and look forward to working with the agency to help more patients access these potentially life-changing insights.”
The FDA grants Breakthrough Device designation to select qualifying devices that may offer improved treatment or diagnosis of life-threatening or irreversibly debilitating diseases when compared to currently available alternatives. The Breakthrough Devices Program is intended to provide patients and healthcare providers with timely access to medical devices by speeding up development, assessment and review.
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. The test is currently marketed as a Laboratory Developed Test (LDT), and through March 31, 2025, has been ordered more than 200,000 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 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, TissueCypher, 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: DecisionDx-Melanoma’s ability to provide (i) comprehensive, personalized results to guide risk-aligned management decisions for patients diagnosed with stage I-III cutaneous melanoma, (ii) valuable biological insights to help inform clinicians; post-diagnoses decision making and (iii) precise and clinically meaningful risk stratification and accurate predictions of sentinel lymph node positivity; DecisionDx-Melanoma’s performance versus other tests currently on the market; Castle’s potential plans to seek Premarket Approval for DecisionDx-Melanoma. 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, our Quarterly Report for the three months ended March 31, 2025, 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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