New Data at AFS 2024 Demonstrates the Strength of Castle Biosciences’ TissueCypher® Test in Independently Predicting Risk of Developing Esophageal Cancer, Guiding Risk-Aligned Management Decisions for Patients with Barrett’s Esophagus
Castle Biosciences will present new data on its TissueCypher Barrett's Esophagus test at the American Foregut Society 2024 Annual Meeting. The data demonstrates the test's ability to independently predict the risk of esophageal cancer progression in patients with Barrett's esophagus (BE).
Key findings include:
- TissueCypher alone is the strongest predictor of progression to esophageal cancer, outperforming combinations with clinicopathologic risk factors.
- For non-dysplastic BE patients, TissueCypher was the only significant predictor of progression.
- The test guided risk-aligned management decisions in 86% of patients, leading to upstaged management in 21% and supporting long-interval surveillance in 90% of low-risk patients.
These results highlight TissueCypher's clinical value in identifying high-risk patients and tailoring treatment plans based on cancer progression likelihood.
Castle Biosciences presenterà nuovi dati sul suo test TissueCypher per l'esofago di Barrett durante l'Annual Meeting della American Foregut Society 2024. I dati dimostrano la capacità del test di prevedere in modo indipendente il rischio di progressione del cancro esofageo nei pazienti con esofago di Barrett (BE).
I principali risultati includono:
- TissueCypher da solo è il miglior indicatore di progressione verso il cancro esofageo, superando le combinazioni con fattori di rischio clinico-patologici.
- Per i pazienti con BE non displastico, TissueCypher è stato l'unico indicatore significativo di progressione.
- Il test ha guidato decisioni di gestione allineate al rischio nell'86% dei pazienti, portando a un'adeguamento della gestione nel 21% e supportando il monitoraggio a lungo intervallo nel 90% dei pazienti a basso rischio.
Questi risultati evidenziano il valore clinico di TissueCypher nell'identificare pazienti ad alto rischio e nel personalizzare i piani di trattamento in base alla probabilità di progressione del cancro.
Castle Biosciences presentará nuevos datos sobre su prueba TissueCypher para el esófago de Barrett en la Reunión Anual de la American Foregut Society 2024. Los datos demuestran la capacidad de la prueba para predecir de manera independiente el riesgo de progresión del cáncer esofágico en pacientes con esófago de Barrett (BE).
Los hallazgos clave incluyen:
- TissueCypher por sí solo es el predictor más fuerte de progresión a cáncer esofágico, superando combinaciones con factores de riesgo clínico-patológicos.
- Para los pacientes con BE no displásico, TissueCypher fue el único predictor significativo de progresión.
- La prueba guió decisiones de gestión alineadas al riesgo en el 86% de los pacientes, conduciendo a una gestión escalonada en el 21% y apoyando la vigilancia a largo plazo en el 90% de los pacientes de bajo riesgo.
Estos resultados destacan el valor clínico de TissueCypher en la identificación de pacientes de alto riesgo y en la personalización de los planes de tratamiento según la probabilidad de progresión del cáncer.
Castle Biosciences는 2024년 American Foregut Society 연례 회의에서 TissueCypher 바렛식도 검사에 대한 새로운 데이터를 발표할 예정입니다. 이 데이터는 바렛식도(BE) 환자에서 식도암 진행의 위험을 독립적으로 예측할 수 있는 검사 능력을 보여줍니다.
주요 발견 사항은 다음과 같습니다:
- TissueCypher 단독이 식도암으로의 진행을 예측하는 가장 강력한 지표이며, 임상병리학적 위험 요소와의 조합보다 뛰어납니다.
- 비형성이 있는 BE 환자에게 TissueCypher는 진행의 유의미한 지표인 유일한 테스트였습니다.
- 이 검사는 86%의 환자에서 위험 기반의 관리 결정을 안내했으며, 21%에서 관리 수준이 상승했고, 90%의 저위험 환자에게는 장기 감시에 대한 지원이 이루어졌습니다.
이 결과는 TissueCypher의 고위험 환자 식별과 암 진행 가능성에 따른 맞춤 치료 계획 수립의 임상적 가치를 강조합니다.
Castle Biosciences présentera de nouvelles données sur son test TissueCypher pour l'œsophage de Barrett lors de l'Assemblée Annuelle de la American Foregut Society 2024. Les données démontrent la capacité du test à prédire de manière indépendante le risque de progression du cancer de l'œsophage chez les patients atteints de l'œsophage de Barrett (BE).
Les principales conclusions comprennent :
- TissueCypher seul est le meilleur prédicteur de progression vers le cancer de l'œsophage, surpassant des combinaisons avec des facteurs de risque clinicopathologiques.
- Pour les patients atteints de BE non dysplasique, TissueCypher était le seul prédicteur significatif de la progression.
- Le test a guidé des décisions de gestion alignées sur le risque chez 86 % des patients, entraînant une gestion rehaussée chez 21 % et soutenant une surveillance à long terme chez 90 % des patients à faible risque.
Ces résultats soulignent la valeur clinique de TissueCypher dans l'identification des patients à haut risque et l'ajustement des plans de traitement en fonction de la probabilité de progression du cancer.
Castle Biosciences wird neue Daten zu ihrem TissueCypher Barrett-Ösophagus-Test auf dem jährlichen Treffen der American Foregut Society 2024 präsentieren. Die Daten zeigen die Fähigkeit des Tests, das Risiko einer Progression von Speiseröhrenkrebs bei Patienten mit Barrett-Ösophagus (BE) unabhängig vorherzusagen.
Die wichtigsten Ergebnisse umfassen:
- TissueCypher allein ist der stärkste Prädiktor für die Progression zum Speiseröhrenkrebs und übertrifft Kombinationen mit klinisch-pathologischen Risikofaktoren.
- Bei nicht-dysplastischen BE-Patienten war TissueCypher der einzige signifikante Prädiktor für die Progression.
- Der Test leitete risikobasierte Managemententscheidungen bei 86% der Patienten, was zu einem höheren Managementniveau bei 21% führte und in 90% der Niedrigrisiko-Patienten eine langfristige Überwachung unterstützte.
Diese Ergebnisse heben den klinischen Wert von TissueCypher zur Identifizierung von Hochrisikopatienten und zur Anpassung von Behandlungsplänen basierend auf der Wahrscheinlichkeit einer Krebsprogression hervor.
- TissueCypher test demonstrated superior performance in predicting esophageal cancer progression risk
- The test guided risk-aligned management decisions in 86% of patients
- TissueCypher supported long-interval surveillance in 90% of low-risk patients, potentially reducing unnecessary procedures
- None.
Oral abstract will share data showing that TissueCypher alone, compared to combining the test’s results with a patient’s clinicopathologic risk factors, like age and pathology diagnosis, is the strongest predictor of progression to esophageal cancer
Poster will highlight ability of the test to guide important patient management decisions, including upstaging care for high-risk patients and supporting long-interval surveillance for patients at low risk of progression
“The large majority of patients in BE surveillance programs have non-dysplastic BE (NDBE), and so they fall into what is considered a low-risk category in which they are advised to see their doctor every three to five years for an endoscopy,” said Rhonda F. Souza, M.D., gastroenterologist, co-director of the Center for Esophageal Research at Baylor Scott & White Research Institute and co-director of the Center for Esophageal Diseases at Baylor University Medical Center in
“TissueCypher is the first test of its kind developed to offer a solution for this clinical challenge,” said Rebecca Critchley-Thorne, Ph.D., vice president of research and development at Castle Biosciences. “The test continues to demonstrate its substantial value in helping physicians tailor their treatment plans for BE patients based on their likelihood of developing esophageal cancer.”
Details regarding Castle’s presentations at AFS 2024 are included below:
Oral presentation: TissueCypher is the strongest independent predictor of progression in patients with Barrett’s esophagus
Presenting Author: Rhonda F. Souza, M.D
Date & Time: Saturday, Sept. 28, 11:50 a.m.–12 p.m. Mountain Time
Summary: The study aimed to evaluate whether routinely available clinicopathologic factors used to risk stratify patients with BE, including age, sex, BE segment length, hiatal hernia and original pathology diagnosis (non-dysplastic Barrett’s esophagus (NDBE), indefinite for dysplasia (IND) and low-grade dysplasia (LGD)), could be combined with the patient’s TissueCypher risk score to improve the accuracy of predicting progression to high grade dysplasia (HGD) or esophageal cancer within five years. The study showed that the addition of clinicopathologic factors did not improve the predictive performance of the TissueCypher test; in fact, TissueCypher, used alone, was the strongest predictor of progression. In patients with NDBE, TissueCypher was the only significant predictor of progression, supporting its significant clinical utility in identifying high-risk patients in this large population to help determine which may benefit from increased surveillance or early interventions to prevent cancer.
Poster # 42: The tissue systems pathology test guides risk-aligned management decisions in patients with non-dysplastic Barrett's esophagus
Date & Time: Friday, Sept. 27, 12:45–12:50 p.m. Mountain Time
Summary: This study evaluated the clinical utility of the TissueCypher test in guiding risk-aligned clinical management decisions for a series of consecutive patients with NDBE (n=14) at an expert foregut surgery center. The patients received prospective TissueCypher testing, and the ordering physician completed a questionnaire describing their reason for ordering the test, their management plan before and after receiving the test results, and how the test results impacted their management decisions. The study data showed a significant association between patients’ TissueCypher risk class and subsequent management decisions (P=0.01099), with
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 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, DecisionDx-SCC, MyPath 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: (i) Castle’s ability to advance care for patients with BE; (ii) the ability of the TissueCypher test to be the strongest predictor of risk of progression to esophageal cancer in patients with BE based on published studies; and (iii) the ability of the TissueCypher test to guide important patient management decisions, including upstaging care for high-risk patients and supporting long-interval surveillance for patients at low risk of progression. The words “can,” “would” 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 TissueCypher in this press release; actual application of our TissueCypher test 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.
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Investor Contact:
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czuckero@castlebiosciences.com
Media Contact:
amarshall@castlebiosciences.com
Source: Castle Biosciences Inc.
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