Frenzwood, Texas, September 28, 2026 /PRNewswire/ — Castle Biosciences, Inc. (Nasdaq: CSTL) Today, the company announced that a newly published study shows that its TissueCypher ® Barrett’s Esophagus Test has helped guide management decisions that match the risks for patients with non-atypical hyperplasia Barrett’s esophagus (NDBE). The company stated that in this study, clinicians changed their management recommendations in 90% of cases after receiving the TissueCypher results, including upgrading the management for all patients with medium- or high-risk test results, and downgrading the management for 84% of patients with low-risk test results.
A study titled "Guidelines for Organ System Pathology Testing in Doctors Treating Patients with Non-atypical Hyperplasia Barrett's Esophagus: A Case Series from a Gastrointestinal Surgery Center" has been published in Foregut : The Journal of the American Society of Digestive Surgeons ( Foregut : The Journal of the American Foregut Society ).
"All patients in this study had the same diagnosis of non-atypical hyperplasia Barrett's esophagus, but TissueCypher shows that there are differences in their risk of progression," said the study author, Caitlin C, a certified anterior gastrointestinal surgeon at the Keck Medical Center of the University of Southern California in Los Angeles (Keck Medicine of the University of Southern California). "The test results help us to customize management plans based on each patient's individual risk – whether that means closer monitoring or endoscopic eradication treatment for patients with medium or high risk, or extending the monitoring interval for patients with low risk. Ultimately, TissueCypher can help us identify patients with an increased risk of progression who may benefit from earlier monitoring or treatment, while avoiding unnecessary procedures for low-risk patients."
Barrett esophagus (BE) is a precancerous lesion that may progress to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC). Among those undergoing surveillance for Barrett esophagus, the majority are patients with non-dysplastic Barrett esophagus, who are generally considered to have a lower risk of progression. However, traditional clinical and pathological factors may not be able to reliably distinguish the subgroup of patients with an increased risk of progression among this group, highlighting the necessity for more precise risk stratification. To evaluate the clinical utility of TissueCypher in this population, this study assessed 30 patients with non-dysplastic Barrett esophagus who underwent clinical testing at the Keck Medical Center of the University of Southern California.
Main findings of the study:
- TissueCypher Identifies a higher-risk population among patients with non-atypical hyperplasia Barrett's esophagus: The test classifies 17% of patients as medium- or high-risk for progressing to advanced atypical hyperplasia/esophageal adenocarcinoma in the next five years, and 83% of patients as low-risk.
- Patients with medium or high-risk results support upgraded management: All patients with TissueCypher results that are medium or high risk had their management plans upgraded. Among them, 4 patients underwent endoscopic eradication treatment, and 1 patient had the monitoring interval shortened.
- Low-risk outcomes support reduced management: 84% of low-risk patients had their management intensity lowered, including extended monitoring intervals, or endoscopic eradication treatment was no longer recommended.
- Detection results changed management plans or boosted doctors' confidence: For 97% of patients, the TissueCypher results altered management recommendations or increased doctors' confidence in the established treatment plans.
The results of this study were also presented on September 27th at the 2026 American College of Surgeons Clinical Congress held in Washington, D.C. ( American College of Surgeons Clinical Congress 2026 ).
Display information:
- Title: The Impact of Organized Systematic Pathological Testing on Clinical Physicians' Recommended Management Decisions for Patients with Non-atypical Hyperplasia Barrett Esophagus
- Presenter: Katie M, Galvin MD, Keck School of Medicine, University of Southern California
- Match: QS101-1 | Quick - Shots I - Station 1: Bariatric / Foregut
Regarding TissueCypher Barrett's esophagus detection
TissueCypher is a precision medical test designed to predict the individualized risk of patients progressing from Barrett's esophagus to high-grade dysplasia or esophageal adenocarcinoma, and it has been extensively validated. This test is suitable for patients with Barrett's esophagus without dysplasia, those for whom the presence of dysplasia cannot be determined, or those with low-grade dysplasia. Its five-year risk assessment is intended to help doctors customize treatment management based on each patient's risk of developing high-grade dysplasia or esophageal adenocarcinoma.
The company stated that TissueCypher has received support from over 17 peer-reviewed papers and has conducted research on biopsy samples from more than 8,000 patients. Compared to traditional histopathological risk assessment, this test has proven to be the strongest independent predictor of progression. This test utilizes artificial intelligence-based spatial omics methods to identify molecular characteristics that usually precede atypical hyperplasia, thus offering the potential to identify, treat, and manage patients with increased cancer risk at an earlier stage. TissueCypher can be integrated into routine endoscopic practice by analyzing standard esophageal biopsy samples, providing actionable insights without the need for additional procedures.
About Castle Biosciences
Castle Biosciences (Nasdaq ticker: CSTL) is a leading diagnostics company dedicated to improving health through innovative tests that guide patient care. The company focuses primarily on the fields of dermatology and gastroenterology, developing personalized and clinically actionable solutions to help improve disease management and patient outcomes.
The company states that it is people-oriented, empowering patients and clinicians through rigorous, scientific, and advanced testing methods, providing information support for nursing decisions, and helping to develop more confident treatment plans. For more information, please visit www.CastleBiosciences.com.
DecisionDx-Melanoma, DecisionDx-CMSeq, i31-SLNB, i31-ROR, DecisionDx-SCC, MyPath Melanoma, AdvanceAD-Tx, TissueCypher, Esopredict, DecisionDx-UM, DecisionDx-PRAME, and DecisionDx-UMSeq are all trademarks of Castle Biosciences, Inc.
Forward-looking Statements
This press release contains forward-looking statements defined under Section 27A of the revised Securities Act of 1933 and Section 21E of the revised Securities Exchange Act of 1934, which are protected by the “safe harbor” provisions established by these sections. These forward-looking statements include, but are not limited to, statements regarding the ability of TissueCypher to: (i) predict the individualized risk of patients progressing from Barrett’s esophagus to high-grade dysplasia or esophageal adenocarcinoma; (ii) assist clinicians in customizing monitoring and management decisions based on each patient’s individual risk profile; (iii) enable earlier identification and management of patients at increased risk for cancer; and (iv) help reduce patients’ uncertainty. Terms such as “believe”, “can”, “may”, and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these terms. The company acknowledges that it may not be able to actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and investors should not rely excessively on them. Actual results or events may differ significantly from the plans, intentions, and expectations disclosed in the company’s forward-looking statements.
The company states that these forward-looking statements involve risks and uncertainties, which may lead to significant differences between actual results and those stated in the forward-looking statements. These include, but are not limited to: subsequent research or trial results and findings that may contradict earlier research or trial results and findings, or that may not support the results obtained from these studies, including the discussions regarding the company's tests mentioned in this press release; the company's tests may not be able to bring the aforementioned benefits to patients in practical applications; as well as the risks listed under the "Risk Factors" heading in the company's annual report 10-K for the fiscal year ending December 31, 2025, subsequent 10-Q quarterly reports submitted or to be submitted to the U.S. Securities and Exchange Commission (SEC), and other documents submitted to SEC. The above forward-looking statements are only applicable as of the date they are made, and except as required by law, the company assumes no obligation to update any such forward-looking statements.
Investor contact person: Camilla Zuckero
Media contact: Allison Marshall
