Castle Biosciences Announces New York State Department of Health Approval of Its TissueCypher® Barrett’s Esophagus Test
Castle Biosciences (CSTL) has received assay approval from the New York State Department of Health for its TissueCypher Barrett's Esophagus test. This approval marks the completion of New York state approval for all of Castle's tests across its dermatology, gastroenterology and ophthalmology portfolios, as well as its clinical laboratories in Phoenix and Pittsburgh.
TissueCypher is the first AI-driven precision medicine test designed to predict progression risk from Barrett's esophagus (BE) to esophageal cancer. The test analyzes cancer-associated biomarkers and spatial biology features to identify molecular signatures of BE progression before visible tissue changes occur. This tool helps clinicians risk-stratify the estimated 5% of U.S. adults with BE, enabling risk-aligned surveillance or earlier interventions to prevent cancer development.
Castle Biosciences (CSTL) ha ricevuto l'approvazione dei test dal Dipartimento della Salute dello Stato di New York per il suo test TissueCypher per l'esofago di Barrett. Questa approvazione segna il completamento dell'approvazione dello Stato di New York per tutti i test di Castle nei settori dermatologico, gastroenterologico e oftalmologico, così come per i suoi laboratori clinici a Phoenix e Pittsburgh.
TissueCypher è il primo test di medicina di precisione guidato dall'IA progettato per prevedere il rischio di progressione dall'esofago di Barrett (BE) al cancro esofageo. Il test analizza i biomarcatori associati al cancro e le caratteristiche della biologia spaziale per identificare firme molecolari della progressione del BE prima che si verifichino cambiamenti visibili nei tessuti. Questo strumento aiuta i clinici a stratificare il rischio dell'5% circa degli adulti statunitensi con BE, consentendo una sorveglianza allineata con il rischio o interventi precoci per prevenire lo sviluppo del cancro.
Castle Biosciences (CSTL) ha recibido la aprobación de ensayo del Departamento de Salud del Estado de Nueva York para su prueba TissueCypher para el esófago de Barrett. Esta aprobación marca la finalización de la aprobación del estado de Nueva York para todas las pruebas de Castle en sus carteras de dermatología, gastroenterología y oftalmología, así como para sus laboratorios clínicos en Phoenix y Pittsburgh.
TissueCypher es la primera prueba de medicina de precisión impulsada por IA diseñada para predecir el riesgo de progresión del esófago de Barrett (BE) al cáncer esofágico. La prueba analiza biomarcadores asociados al cáncer y características de biología espacial para identificar firmas moleculares de progresión del BE antes de que ocurran cambios visibles en los tejidos. Esta herramienta ayuda a los clínicos a estratificar el riesgo del 5% de los adultos en EE.UU. con BE, lo que permite una vigilancia alineada con el riesgo o intervenciones tempranas para prevenir el desarrollo del cáncer.
캐슬 바이오사이언스 (CSTL)는 뉴욕주 보건부로부터 바렛 식도 검사를 위한 TissueCypher 검사의 승인 을 받았습니다. 이 승인은 캐슬의 피부과, 위장병학 및 안과 포트폴리오 전반에 걸쳐 뉴욕주의 모든 검사에 대한 승인을 완료한 것을 의미합니다. 또한 피닉스와 피츠버그의 클리닉 실험실을 포함합니다.
TissueCypher는 바렛 식도(BE)에서 식도암으로의 진행 위험을 예측하기 위해 설계된 첫 번째 AI 기반 정밀 의학 검사입니다. 이 검사는 암 관련 바이오마커와 공간 생물학적 특성을 분석하여 가시적인 조직 변화가 발생하기 전에 BE 진행의 분자 서명을 식별합니다. 이 도구는 BE가 있는 미국 성인 약 5%의 위험을 분류하는 데 도움을 주어 암 발생을 방지하기 위해 위험에 맞춘 감시 또는 조기 개입을 가능하게 합니다.
Castle Biosciences (CSTL) a reçu l'approbation d'essai du Département de la Santé de l'État de New York pour son test TissueCypher pour l'œsophage de Barrett. Cette approbation marque l'achèvement de l'approbation de l'État de New York pour tous les tests de Castle dans ses portefeuilles de dermatologie, de gastro-entérologie et d'ophtalmologie, ainsi que pour ses laboratoires cliniques à Phoenix et Pittsburgh.
TissueCypher est le premier test de médecine de précision propulsé par l'IA conçu pour prédire le risque de progression de l'œsophage de Barrett (BE) au cancer œsophagien. Le test analyse les biomarqueurs associés au cancer et les caractéristiques de biologie spatiale pour identifier les signatures moléculaires de progression du BE avant l'apparition de changements visibles des tissus. Cet outil aide les cliniciens à stratifier le risque des environ 5 % des adultes américains atteints de BE, permettant ainsi une surveillance alignée sur le risque ou des interventions précoces pour prévenir le développement du cancer.
Castle Biosciences (CSTL) hat die Genehmigung eines Tests vom Gesundheitsministerium des Bundesstaates New York für seinen TissueCypher Barrett-Ösophagus-Test erhalten. Diese Genehmigung markiert den Abschluss der Genehmigung aller Tests von Castle im Bereich Dermatologie, Gastroenterologie und Ophthalmologie im Bundesstaat New York sowie in seinen klinischen Laboren in Phoenix und Pittsburgh.
TissueCypher ist der erste KI-gesteuerte Präzisionsmedizin-Test, der entwickelt wurde, um das Fortschrittsrisiko vom Barrett-Ösophagus (BE) zu Speiseröhrenkrebs vorherzusagen. Der Test analysiert krebsassoziierte Biomarker und räumliche biologische Merkmale, um molekulare Signaturen des BE-Fortschritts zu identifizieren, bevor sichtbare Gewebeveränderungen auftreten. Dieses Werkzeug hilft Klinikern, das Risiko der schätzungsweise 5 % der US-Erwachsenen mit BE zu stratifizieren, was eine risikogerechte Überwachung oder frühere Interventionen zur Verhinderung der Krebsentwicklung ermöglicht.
- Received full NYSDOH approval for TissueCypher test, completing approval for entire test portfolio
- First-mover advantage with AI-driven precision medicine test in Barrett's esophagus market
- Addresses large market opportunity with 5% of U.S. adults having Barrett's esophagus
- None.
Insights
The NYSDOH approval for TissueCypher represents a pivotal regulatory milestone that unlocks access to the entire New York market, one of the largest healthcare markets in the US. The test's AI-driven approach to predicting Barrett's esophagus progression addresses a critical medical need, considering that 5% of US adults have BE and esophageal cancer has a dismal 22% five-year survival rate.
The molecular diagnostic's ability to detect cancer-associated biomarkers before visible tissue changes positions it as an early intervention tool that could significantly impact patient outcomes. This approval completes Castle's portfolio authorization in New York state, strengthening their market position in molecular diagnostics. The test's unique capability to analyze spatial biology features and molecular signatures provides a competitive advantage in the growing precision medicine market.
For investors, this regulatory clearance reduces market access barriers and expands the addressable patient population, potentially accelerating revenue growth. The comprehensive approval of Castle's test portfolio in New York enhances the company's competitive positioning and validates their technical capabilities in AI-driven diagnostics.
This regulatory approval significantly expands Castle Biosciences' commercial opportunities in New York, a key market that typically represents 6-8% of the US healthcare market. The approval's timing is strategic, as the molecular diagnostics market is experiencing rapid growth, particularly in AI-enabled precision medicine solutions.
The completion of Castle's portfolio approval in New York strengthens their competitive moat and could drive increased adoption among healthcare providers who prefer working with fully-approved diagnostic partners. The TissueCypher test addresses an underserved market segment with substantial growth potential, given the high prevalence of Barrett's esophagus and the increasing incidence of esophageal cancer.
From a market perspective, this approval could catalyze increased institutional investor interest, as it demonstrates Castle's execution capability and regulatory compliance track record. The expansion of their testing capabilities in both Phoenix and Pittsburgh laboratories also indicates operational scalability, which is important for long-term growth potential.
With this approval, all of the tests in Castle’s dermatology, gastroenterology and ophthalmology portfolios, as well as its clinical laboratories in
“We are proud of the expansion of our New York Clinical Laboratory Permit to include our TissueCypher test,” said Kristen Oelschlager, chief operating officer of Castle Biosciences. “We believe this shift from conditional to full approval by the NYSDOH exemplifies Castle’s commitment to providing high-quality, molecular tests that can guide informed care decisions and improve patients’ lives.”
“Successful completion of the rigorous
With access to TissueCypher, clinicians have a prognostic tool designed to risk stratify the estimated
About TissueCypher Barrett’s Esophagus Test
The TissueCypher Barrett’s Esophagus test is Castle’s precision medicine test designed to predict future development of high-grade dysplasia (HGD) and/or esophageal cancer in patients with Barrett’s esophagus (BE). The TissueCypher Barrett’s Esophagus test is indicated for use in patients with endoscopic biopsy confirmed BE that is graded non-dysplastic (NDBE), indefinite for dysplasia (IND) or low-grade dysplasia (LGD); its clinical performance has been supported by 14 peer-reviewed publications of BE progressor patients with leading clinical centers around the world. The test received Advanced Diagnostic Laboratory Test (ADLT) status from the Centers for Medicare & Medicaid Services (CMS) in March 2022. 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 for use in patients diagnosed with moderate-to-severe atopic dermatitis who are seeking systemic 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 Castle’s tests to guide informed care decisions and improve patients’ lives; Castle’s ability to ensure that all patients with BE in
- National Institute of Diabetes and Digestive and Kidney Diseases. Last Reviewed August 2024. Accessed December 12, 2024. https://www.niddk.nih.gov/health-information/digestive-diseases/barretts-esophagus/definition-facts.
- Siegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA Cancer J Clin. 2024;74(1):12-49. doi:10.3322/caac.21820. https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21820; accessed 11/5/24
View source version on businesswire.com: https://www.businesswire.com/news/home/20250106714830/en/
Investor Contact:
Camilla Zuckero
czuckero@castlebiosciences.com
Media Contact:
amarshall@castlebiosciences.com
Source: Castle Biosciences Inc.
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