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Castle Biosciences Surpasses 25,000 Test Reports Delivered for its TissueCypher® Barrett’s Esophagus Test

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Castle Biosciences, a precision medicine company, announced a milestone for its TissueCypher Barrett’s Esophagus test, surpassing 25,000 test reports delivered since acquiring the test in late 2021. TissueCypher predicts the risk of progression from Barrett’s esophagus (BE) to esophageal cancer. BE is the only known precursor to esophageal adenocarcinoma, a rapidly increasing cancer in the U.S. with a five-year survival rate of 22%. TissueCypher, supported by 14 peer-reviewed studies, outperforms traditional pathology diagnoses, providing personalized risk scores and actionable insights. This test can help clinicians make informed decisions, potentially preventing esophageal cancer through tailored surveillance and intervention strategies.

Castle Biosciences, un'azienda di medicina di precisione, ha annunciato un traguardo per il suo test TissueCypher per l'esofago di Barrett, superando le 25.000 relazioni di test consegnate da quando ha acquisito il test alla fine del 2021. TissueCypher predice il rischio di progressione dall'esofago di Barrett (BE) al cancro esofageo. Il BE è l'unico precursore noto dell'adenocarcinoma esofageo, un tumore in rapida crescita negli Stati Uniti con un tasso di sopravvivenza a cinque anni del 22%. TissueCypher, supportato da 14 studi con revisione paritaria, supera le diagnosi patologiche tradizionali, fornendo punteggi di rischio personalizzati e approfondimenti utili. Questo test può aiutare i clinici a prendere decisioni informate, potenzialmente prevenendo il cancro esofageo attraverso strategie di sorveglianza e intervento su misura.

Castle Biosciences, una empresa de medicina de precisión, anunció un hito para su prueba TissueCypher para el esófago de Barrett, superando los 25,000 informes de pruebas entregados desde que adquirió la prueba a finales de 2021. TissueCypher predice el riesgo de progresión del esófago de Barrett (BE) al cáncer esofágico. BE es el único precursor conocido del adenocarcinoma esofágico, un cáncer de rápido aumento en EE. UU. con una tasa de supervivencia a cinco años del 22%. TissueCypher, respaldado por 14 estudios revisados por pares, supera los diagnósticos patológicos tradicionales, proporcionando puntajes de riesgo personalizados y conocimientos aplicables. Esta prueba puede ayudar a los clínicos a tomar decisiones informadas, potencialmente previniendo el cáncer esofágico a través de estrategias de vigilancia e intervención personalizadas.

Castle Biosciences는 정밀의학 회사로서, 2021년 말 해당 검사를 인수한 이후 25,000건 이상의 TissueCypher 바렛 식도 검사 보고서를 전달했다는 이정표를 발표했습니다. TissueCypher는 바렛 식도(BE)에서 식도암으로 진행될 위험을 예측합니다. BE는 식도 선암의 유일한 알려진 전신으로, 미국에서 빠르게 증가하는 암으로 5년 생존율은 22%입니다. 14개의 동료 검토 연구에 의해 뒷받침되는 TissueCypher는 전통적인 병리학적 진단을 초월하며, 개인별 위험 점수와 실행 가능한 통찰을 제공합니다. 이 검사는 임상의들이 정보에 기반한 결정을 내리는 데 도움을 줄 수 있으며, 맞춤형 감시 및 개입 전략을 통해 식도암 예방에 기여할 수 있습니다.

Castle Biosciences, une entreprise de médecine de précision, a annoncé un jalon pour son test TissueCypher pour l'œsophage de Barrett, dépassant les 25 000 rapports de test livrés depuis l'acquisition du test à la fin de 2021. TissueCypher prédit le risque de progression de l'œsophage de Barrett (BE) au cancer de l'œsophage. Le BE est le seul précurseur connu de l'adénocarcinome œsophagien, un cancer en forte augmentation aux États-Unis avec un taux de survie à cinq ans de 22%. TissueCypher, soutenu par 14 études évaluées par des pairs, surpasse les diagnostics pathologiques traditionnels, offrant des scores de risque personnalisés et des informations exploitables. Ce test peut aider les cliniciens à prendre des décisions éclairées, en prévenant potentiellement le cancer de l'œsophage grâce à des stratégies de surveillance et d'intervention sur mesure.

Castle Biosciences, ein Unternehmen für Präzisionsmedizin, hat einen Meilenstein für seinen TissueCypher-Test für die Barrett-Ösophagus aufgestellt und seit der Übernahme des Tests Ende 2021 über 25.000 Testberichte geliefert. TissueCypher sagt das Risiko der Progression von Barrett-Ösophagus (BE) zu Speiseröhrenkrebs voraus. BE ist der einzige bekannte Vorläufer des Ösophagusadenokarzinoms, einer in den USA schnell ansteigenden Krebsart mit einer Fünfjahresüberlebensrate von 22%. TissueCypher, unterstützt von 14 begutachteten Studien, übertrifft traditionelle pathologische Diagnosen, indem es personalisierte Risikopunkte und umsetzbare Einblicke bietet. Dieser Test kann Kliniker dabei unterstützen, informierte Entscheidungen zu treffen und möglicherweise Speiseröhrenkrebs durch maßgeschneiderte Überwachungs- und Interventionsstrategien zu verhindern.

Positive
  • Castle Biosciences surpassed 25,000 test reports for TissueCypher since late 2021.
  • TissueCypher provides personalized risk scores for Barrett’s esophagus progression.
  • The test is supported by 14 peer-reviewed studies, enhancing its credibility.
Negative
  • None.

TissueCypher is Castle’s precision medicine risk-stratification test that predicts a patient’s individual risk of progression from Barrett’s esophagus (BE) to esophageal cancer

FRIENDSWOOD, Texas--(BUSINESS WIRE)-- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced a significant milestone for the Company’s TissueCypher Barrett’s Esophagus test, which surpassed 25,000 test reports delivered since the Company acquired the test at the end of 2021.

“At Castle, improving patient care is central to our mission,” said Toby Juvenal, chief commercial officer at Castle Biosciences. “We are extremely proud to have achieved this important milestone for our TissueCypher test, as we believe it means more clinicians are recognizing the value of the personalized, risk-aligned insights this test can provide, empowering them to make more informed decisions for their Barrett’s patients — decisions that could ultimately prevent an esophageal cancer diagnosis down the road.”

BE is the only known precursor to esophageal adenocarcinoma, the most common type of esophageal cancer.1 Esophageal cancer is one of the fastest-growing cancers in incidence in the United States with a five-year survival rate of just 22%.2 TissueCypher is the first AI-driven precision medicine test designed to determine a patient’s individual risk of progression from BE to esophageal cancer. The test is currently supported by 14 peer-reviewed clinical validation and utility studies that encompass one of the largest sets of BE progressor patients ever assembled.3 In these studies, TissueCypher consistently outperforms pathology diagnosis and BE segment length as predictors of progression, providing physicians with an actionable risk score and a patient's personalized five-year risk of progression. A low-risk test result can enable the extension of surveillance intervals or a reduction in unnecessary medical procedures for patients, while a high-risk result may prompt increased surveillance or intervention, like radiofrequency ablation, to help prevent a patient’s progression to esophageal cancer.

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, 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 TissueCypher test to (i) empower clinicians to make more informed decisions for their patients with BE that could ultimately prevent future esophageal cancer diagnoses; (ii) determine a patient’s individual risk of progression from BE to esophageal cancer; (iii) provide physicians with an actionable risk score and a patient's personalized five-year risk of progression; and (iv) help prevent unnecessary medical procedures. 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 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.

  1. Curtius K, Rubenstein JH, Chak A, Inadomi JM. Computational modelling suggests that Barrett’s oesophagus may be the precursor of all oesophageal adenocarcinomas. Gut. Published online November 24, 2020:gutjnl-2020-321598. doi:10.1136/gutjnl-2020-321598. https://pubmed.ncbi.nlm.nih.gov/33234525/; accessed 11/5/24
  2. 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
  3. TissueCypher published clinical validation and utility studies; https://castlebiosciences.com/Files/TC-006v3-052022%20Pub%20Clin%20Vali-Util%20Stds_INTERACTIVE%20%281%29.pdf; accessed 11/5/24

Investor Contact:

Camilla Zuckero

czuckero@castlebiosciences.com

Media Contact:

Allison Marshall

amarshall@castlebiosciences.com

Source: Castle Biosciences Inc.

FAQ

What milestone did Castle Biosciences achieve with TissueCypher?

Castle Biosciences surpassed 25,000 test reports delivered for its TissueCypher Barrett’s Esophagus test.

What does the TissueCypher test predict?

TissueCypher predicts the risk of progression from Barrett’s esophagus to esophageal cancer.

What is the significance of Barrett’s esophagus in cancer progression?

Barrett’s esophagus is the only known precursor to esophageal adenocarcinoma, the most common type of esophageal cancer.

How does TissueCypher compare to traditional methods?

TissueCypher outperforms traditional pathology diagnoses and BE segment length in predicting progression to esophageal cancer.

How does TissueCypher benefit clinicians and patients?

TissueCypher provides personalized risk scores, enabling informed decisions that can extend surveillance intervals or prompt interventions to prevent esophageal cancer.

Castle Biosciences, Inc.

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