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Castle Biosciences Publishes Study Showing TissueCypher Test Guides Management Decisions
Castle Biosciences announced the publication of a study showing that its TissueCypher Barrett's Esophagus Test helped guide risk-aligned management decisions for patients with non-dysplastic Barrett's esophagus. In the study, clinicians changed their management recommendations 90% of the time after receiving TissueCypher results, including escalating management for all patients with intermediate- or high-risk results and de-escalating management for 84% of those with low-risk results. The study, titled "The Tissue Systems Pathology Test Guides Physician Recommendations for Patients With Non-Dysplastic Barrett's Esophagus: A Case Series From a Gastrointestinal Surgery Center," was published in Foregut: The Journal of the American Foregut Society.
Castle Biosciences Publishes TissueCypher Study Results
Castle Biosciences announced the publication of a new decision modeling study showing that the TissueCypher Barrett's Esophagus test - TSP-9 - can help better align Barrett's esophagus, or BE, management with a patient's individual risk of progression to high-grade dysplasia, or HGD, or esophageal adenocarcinoma - EAC -. In the study, simulated use of TissueCypher significantly increased appropriate management aligned with known progression outcomes across patients with non-dysplastic BE - NDBE -, indefinite for dysplasia - IND - and low-grade dysplasia, or LGD. The study will be published in the Annals of Gastroenterology. BE is a pre-malignant condition that can progress to EAC, a cancer with poor long-term survival. Across all of the patients with BE in the study, incorporating TissueCypher results into management decisions would have significantly increased the percentage of patients receiving appropriate management from 59.8% to 75.3%. These findings underscore TissueCypher's ability to support more individualized BE management by helping clinicians escalate care for patients at higher risk of progression while avoiding unnecessary procedures for those at lower risk.
Castle Biosciences Publishes Study on High-Risk Skin SCC
Castle Biosciences announced the publication of a multi-center study in the Journal of the American Academy of Dermatology, or JAAD, validating the integrated DecisionDx-SCC test result for patients with high-risk cutaneous squamous cell carcinoma. DecisionDx-SCC analyzes 40 genes to provide results related to prognosis and response to adjuvant radiation therapy based on an individual patient's tumor biology. The enhanced algorithm integrates the molecular data with five clinicopathologic risk factors using optimized nested predictive models. This integrated approach provides an assessment of metastatic risk, local recurrence risk and likelihood of benefit from ART. The study published in JAAD showed that the test results can shift or stratify patients across clinically actionable risk thresholds, supporting risk-aligned decisions regarding patient follow-up, surveillance imaging, multidisciplinary referral and ART. The study evaluated the enhanced DecisionDx-SCC algorithm in an independent validation cohort of 572 patients with high-risk SCC. DecisionDx-SCC significantly stratified patients by metastatic and local recurrence risk. In multivariable analysis, the test results provided significant predictive information beyond individual clinicopathologic risk factors for both outcomes. Nearly half of patients in the cohort were classified by the i40-GEP test as Class 1A. This result demonstrated a 97.3% negative predictive value (NPV) and may support greater confidence when considering de-escalation of care in low-risk patients. The refined algorithm classified 12.9% of patients as Class 2B. These patients had a three-year metastasis-free survival rate of 66.2%, compared with 97.3% for patients with Class 1A test results. In multivariable analysis, Class 2B patients were 10.7 times more likely to develop metastasis than Class 1A patients, demonstrating strong separation between the test's lowest- and highest-risk results. In addition, the Class 2B result identified patients with a high likelihood of benefitting from ART. Patients with Class 2B test results who were treated with ART had an approximately 50% lower median metastatic progression rate at five years than those who did not receive ART. Class 2B ART-treated patients also showed significantly delayed disease progression with decreased acceleration of events compared to Class 2B patients who did not receive ART. No significant difference was observed between ART-treated and untreated patients with Class 2A test results. DecisionDx-SCC demonstrated greater accuracy in predicting metastatic risk than National Comprehensive Cancer Network risk groups and Brigham and Women's Hospital staging.
Castle Biosciences' TissueCypher Test Orders Exceed 100,000
Castle Biosciences' TissueCypher Barrett's Esophagus Test has surpassed 100,000 clinical test orders. TissueCypher is an AI-derived precision medicine test designed to predict a patient's five-year risk of progression from Barrett's esophagus to high-grade dysplasia or esophageal adenocarcinoma. For some patients, understanding their risk of progression may help reduce uncertainty after diagnosis. TissueCypher is a precision medicine test designed and extensively validated to predict a patient's personalized risk of progression from Barrett's esophagus to high-grade dysplasia or esophageal adenocarcinoma. TissueCypher's five-year risk assessment is designed to help physicians tailor care to each patient's risk of developing HGD or EAC.
Castle Biosciences Q1 Revenue $83.7M, Raises 2026 Revenue Guidance to $345M-$355M
Reports Q1 revenue $83.7M, consensus $79.23M. "The Castle Biosciences team delivered outstanding results to start 2026, delivering $83.7M in revenue," said CEO Derek Maetzold. "Our momentum this quarter reflects our robust execution and the strength of our core revenue drivers, with both DecisionDx-Melanoma and TissueCypher achieving double digit year-over-year test volume growth, 16% and 58%, respectively. As a result of our first quarter performance and continued confidence in the business, we are raising our 2026 total revenue guidance to $345M-$355M vs. the previously provided guidance of $340M-350M. In addition, during the quarter we expanded the body of evidence supporting our market-leading DecisionDx-Melanoma test...Our substantial body of evidence is a key driver of adoption and an important differentiator for DecisionDx-Melanoma and our innovative test portfolio more broadly, reinforcing our position of strength as we continue to execute across the business."
This page is for research only and is not investment advice. Models can be wrong. Past performance does not guarantee future results.







