New Data at American Foregut Society's 2025 Annual Meeting Demonstrates TissueCypher庐 Can Detect High-Risk Barrett鈥檚 Esophagus Patients Not Identified by Pathology to Support Improved Care Decisions
Castle Biosciences (Nasdaq: CSTL) announced new data for their TissueCypher Barrett's Esophagus test to be presented at the American Foregut Society's 2025 Annual Meeting. The study of 85 patients revealed that TissueCypher identified 15% of patients with non-dysplastic Barrett's esophagus (NDBE) as having intermediate or high risk of progression to cancer, despite their seemingly low-risk pathology results.
The study showed patients with intermediate-risk scores had a 9% median five-year progression probability, while high-risk scores indicated a 16% probability. These rates exceed the 8.5% five-year risk threshold associated with low-grade dysplasia, where guidelines recommend more frequent surveillance or treatment. The findings demonstrate TissueCypher's ability to provide more precise risk assessment beyond standard pathology, potentially enabling personalized treatment strategies for preventing esophageal cancer.
Castle Biosciences (Nasdaq: CSTL) ha annunciato nuovi dati sul test TissueCypher per l'esofago di Barrett, che saranno presentati all'Annual Meeting 2025 dell'American Foregut Society. Lo studio su 85 pazienti ha rilevato che TissueCypher ha identificato il 15% dei pazienti con esofago di Barrett non displastico (NDBE) come a rischio intermedio o alto di progressione verso il cancro, nonostante risultati patologici apparentemente a basso rischio.
Lo studio ha mostrato che i pazienti con punteggi di rischio intermedio avevano una probabilit脿 mediana di progressione a cinque anni del 9%, mentre i punteggi di rischio alto indicavano una probabilit脿 del 16%. Queste percentuali superano la soglia del 8,5% di rischio a cinque anni associata alla displasia di basso grado, per la quale le linee guida raccomandano sorveglianza pi霉 frequente o trattamento. I risultati dimostrano la capacit脿 di TissueCypher di fornire una valutazione del rischio pi霉 precisa rispetto alla sola patologia, potenzialmente permettendo strategie di trattamento personalizzate per prevenire il cancro esofageo.
Castle Biosciences (Nasdaq: CSTL) anunci贸 nuevos datos de su prueba TissueCypher para el es贸fago de Barrett, que se presentar谩n en la Reuni贸n Anual 2025 de la American Foregut Society. El estudio de 85 pacientes mostr贸 que TissueCypher identific贸 al 15% de los pacientes con Barrett no displ谩sico (NDBE) como de riesgo intermedio o alto de progresi贸n a c谩ncer, a pesar de sus resultados patol贸gicos aparentemente de bajo riesgo.
El estudio revel贸 que los pacientes con puntuaciones de riesgo intermedio ten铆an una probabilidad mediana de progresi贸n a cinco a帽os del 9%, mientras que las puntuaciones de alto riesgo indicaron una probabilidad del 16%. Estas tasas superan el 8,5% de riesgo a cinco a帽os asociado con la displasia de bajo grado, para la cual las gu铆as recomiendan vigilancia m谩s frecuente o tratamiento. Los hallazgos demuestran la capacidad de TissueCypher para ofrecer una evaluaci贸n de riesgo m谩s precisa que la patolog铆a est谩ndar, lo que podr铆a permitir estrategias de tratamiento personalizadas para prevenir el c谩ncer de es贸fago.
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鞐瓣惮 瓴瓣臣 欷戨摫霃� 鞙勴棙 鞝愳垬毳� 氚涭潃 頇橃瀽電� 5雲� 欷戩暀 歆勴枆 頇曤 9%毳� 氤挫榾瓿�, 瓿犾渼項� 鞝愳垬電� 16%鞚� 頇曤鞚� 雮橅儉雰堨姷雼堧嫟. 鞚� 牍勳湪霌れ潃 鞝�霌标笁 鞚错槙靹标臣 鞐瓣磤霅� 5雲� 鞙勴棙 8.5% 旮办鞚� 齑堦臣頃橂┌, 鞝� 旮办鞐愳劀電� 臧�鞚措摐霛检澑鞚� 雿� 鞛潃 臧愳嫓雮� 旃橂毳� 甓岇灔頃╇媹雼�. 鞚� 瓴瓣臣電� TissueCypher臧� 響滌 氤戨Μ 瓴�靷ゼ 雱橃柎 氤措嫟 鞝曧檿頃� 鞙勴棙 韽夑皜毳� 鞝滉车頃橃棳 鞁濍弰鞎� 鞓堧癌鞚� 鞙勴暅 臧滌澑頇旊悳 旃橂 鞝勲灥鞚� 臧�電ロ晿瓴� 頃� 靾� 鞛堨潓鞚� 氤挫棳欷嶋媹雼�.
Castle Biosciences (Nasdaq: CSTL) a annonc茅 de nouvelles donn茅es sur son test TissueCypher pour l'艙sophage de Barrett, qui seront pr茅sent茅es lors de la r茅union annuelle 2025 de l'American Foregut Society. L'茅tude portant sur 85 patients a r茅v茅l茅 que TissueCypher identifiait 15% des patients atteints de Barrett non dysplasique (NDBE) comme pr茅sentant un risque interm茅diaire ou 茅lev茅 de progression vers un cancer, malgr茅 des r茅sultats pathologiques apparemment 脿 faible risque.
L'茅tude a montr茅 que les patients ayant des scores de risque interm茅diaire avaient une probabilit茅 m茅diane de progression 脿 cinq ans de 9%, tandis que les scores 茅lev茅s indiquaient une probabilit茅 de 16%. Ces taux d茅passent le risque 脿 cinq ans de 8,5% associ茅 脿 la dysplasie de bas grade, pour lequel les recommandations pr茅conisent une surveillance plus fr茅quente ou un traitement. Les r茅sultats d茅montrent la capacit茅 de TissueCypher 脿 fournir une 茅valuation du risque plus pr茅cise que la seule pathologie standard, permettant potentiellement des strat茅gies de traitement personnalis茅es pour pr茅venir le cancer de l'艙sophage.
Castle Biosciences (Nasdaq: CSTL) gab neue Daten zu ihrem TissueCypher-Test f眉r Barrett-脰sophagus bekannt, die auf dem Jahrestreffen 2025 der American Foregut Society vorgestellt werden. Die Studie mit 85 Patienten ergab, dass TissueCypher 15% der Patienten mit nicht-dysplastischem Barrett-脰sophagus (NDBE) als mittel- oder hochriskant f眉r eine Progression zu Krebs einstufte, obwohl ihre pathologischen Befunde scheinbar niedriges Risiko zeigten.
Die Studie zeigte, dass Patienten mit mittlerem Risikowert eine median 5-Jahres-Progressionswahrscheinlichkeit von 9% hatten, w盲hrend hohe Risikowerte eine Wahrscheinlichkeit von 16% anzeigten. Diese Raten liegen 眉ber der 5-Jahres-Risiko-Schwelle von 8,5%, die mit Low-Grade-Dysplasie verbunden ist und f眉r die Leitlinien h盲ufigere 脺berwachung oder Behandlung empfehlen. Die Ergebnisse zeigen, dass TissueCypher eine pr盲zisere Risikobewertung als die Standardpathologie liefern kann und damit personalisierte Behandlungsstrategien zur Verhinderung von Speiser枚hrenkrebs erm枚glichen k枚nnte.
- None.
- Study sample size was relatively small with only 85 patients
In the study, TissueCypher identified that
FRIENDSWOOD, Texas, Sept. 09, 2025 (GLOBE NEWSWIRE) -- Castle Biosciences, Inc.聽(Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced that new data demonstrating the personalized risk stratification provided by its TissueCypher Barrett鈥檚 Esophagus test will be shared via a podium presentation at the American Foregut Society's (AFS) 2025 Annual Meeting, taking place Sept. 11-13, 2025, in Dallas.
"The findings being presented at AFS underscore the importance of moving beyond standard pathology when assessing progression risk in patients with Barrett鈥檚 esophagus,鈥� said lead study author Caitlin C. Houghton, M.D., board-certified foregut surgeon at Keck Medicine of USC in Los Angeles. 鈥淭issueCypher provides an added level of precision that is designed to reveal high-risk patients who might otherwise be overlooked, potentially enabling personalized surveillance and treatment strategies aimed at reducing their chances of developing esophageal cancer."
Details regarding the podium presentation are included below:
Title: Patients With Non-Dysplastic Barrett鈥檚 Esophagus Received Individualized Risk Stratification With the Tissue Systems Pathology Test
- Presenter and Lead Author: Caitlin C. Houghton, M.D.
- Session: AFS Podium Presentations
- Date & Time: Saturday, September 13, 10-10:10 a.m. Central time
- Location: Tate B
For patients with Barrett鈥檚 esophagus (BE), regular endoscopic surveillance is intended to catch signs of disease progression early, when endoscopic eradication therapy (EET) can be most effective in preventing advancement to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC). Many doctors rely on a patient鈥檚 clinical history and pathology results to estimate cancer risk and set intervals for follow-up endoscopic surveillance. These population-based risk estimates have done little to slow the rising incidence of esophageal cancer. This underscores the need for more precise tools, like TissueCypher, that can help identify a patient鈥檚 individual risk of progressing to cancer and guide care that is better aligned to that risk.
This study evaluated TissueCypher鈥檚 ability to stratify risk in 85 patients diagnosed with NDBE who received test results from four surgical practices. Patients with NDBE are generally considered to have the lowest risk of cancer progression, and current guidelines recommend surveillance every three to five years. However, while
These findings show that TissueCypher can deliver clinically meaningful risk insights that can help physicians better tailor care for patients with BE. Notably, patients in the study with intermediate- and high-risk scores had similar or greater predicted progression risk than patients diagnosed with LGD, despite having a NDBE diagnosis. By identifying low-risk patients whose care can follow guideline-based surveillance intervals and intermediate- and high-risk patients who may benefit from earlier intervention, TissueCypher can potentially support more precise, risk-aligned management aimed at preventing disease progression.
For more information on the TissueCypher test, please visit Castle at exhibit #22.
About TissueCypher聽Barrett鈥檚 Esophagus Test
The TissueCypher聽Barrett鈥檚 Esophagus test is Castle鈥檚 precision medicine test designed to predict future development of high-grade dysplasia (HGD) and/or esophageal cancer in patients with Barrett鈥檚 esophagus (BE). The TissueCypher Barrett鈥檚 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 16 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.
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鈥檚 current portfolio consists of tests for skin cancers, Barrett鈥檚 esophagus and uveal melanoma.聽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聽 and connect with us on聽,听,听 补苍诲听.鈥�
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 鈥渟afe harbor鈥� created by those sections. These forward-looking statements include, but are not limited to, statements concerning: TissueCypher鈥檚 ability to play an important role in identifying BE patients at higher risk for progression to esophageal cancer, and enable more personalized surveillance and treatment strategies for BE patients that help prevent cancer. The words 鈥渂elieve,鈥� 鈥渃an鈥� 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 鈥淩isk Factors鈥� in our Annual Report on Form 10-K for the year ended December 31, 2024, and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, each as filed with the SEC, 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
Media Contact:
Allison Marshall
Source: Castle Biosciences, Inc.
FAQ
What were the key findings of Castle Biosciences' (CSTL) TissueCypher study presented at AFS 2025?
How does TissueCypher improve Barrett's esophagus patient care compared to standard pathology?
What are the progression risks identified by Castle Biosciences' TissueCypher test?
When and where will Castle Biosciences (CSTL) present the TissueCypher data?
What percentage of patients in the CSTL TissueCypher study received low-risk results?
