New Study Shows That TissueCypher® Changed Management at an Expert Surgery Center in 90% of Patients With Non-Dysplastic Barrett's Esophagus

All 30 patients shared a non-dysplastic diagnosis, while their test results placed them in different five-year risk categories.

Rhea-AI Summary

Castle Biosciences (CSTL) reported a published study in which TissueCypher results changed management recommendations for 90% of patients.

The case series covered 30 patients with non-dysplastic Barrett's esophagus tested during care at Keck Medical Center of USC. TissueCypher classified 17% as intermediate or high risk of progression to high-grade dysplasia or esophageal adenocarcinoma within five years, and 83% as low risk. Clinicians escalated management for all intermediate- or high-risk patients, including endoscopic eradication therapy for four and shorter-interval surveillance for one. They de-escalated management for 84% of low-risk patients. Results changed recommendations or increased physician confidence for 97% of patients.

Market Context

On Sep 15, the related TissueCypher decision model reported appropriate management increasing from 5...

Analysis

On Sep 15, the related TissueCypher decision model reported appropriate management increasing from 59.8% to 75.3%; it provides a prior Barrett's benchmark, while this release reports clinician decisions in a case series.

Key Figures

Management recommendations changed: 90% Low-risk management de-escalated: 84% Study participants: 30 patients +5 more

Management recommendations changed

90%

After clinicians received TissueCypher results

Low-risk management de-escalated

84%

Patients with low-risk TissueCypher results

Study participants

30 patients

NDBE patients tested at Keck Medical Center of USC

Intermediate- or high-risk classification

17%

Patients classified for progression to HGD/EAC within five years

Low-risk classification

83%

Patients classified by TissueCypher

Management changed or physician confidence increased

97%

Patients in the study

Endoscopic eradication therapy

4 patients

Intermediate- or high-risk patients with escalated management

Shorter-interval surveillance

1 patient

Intermediate- or high-risk patient with escalated management

Historical Context

1 past event · Latest: Sep 15

1 event

1. Sep 15

   clinical study

   24h Move

   +6.2%

   A pooled decision model reported higher appropriate-management rates with TissueCypher across Barrett's cohorts.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

high-grade dysplasia, esophageal adenocarcinoma, endoscopic eradication therapy, risk stratification

4 terms

high-grade dysplasia medical

"can progress to high-grade dysplasia (HGD) or esophageal adenocarcinoma"

High-grade dysplasia is a severe abnormal change in cells of a tissue that looks much closer to cancer than normal cells and carries a high risk of becoming invasive cancer if not treated. For investors, it matters because diagnosis, treatment, or clinical trial results involving high-grade dysplasia can directly affect regulatory decisions, projected medical costs, market demand for therapies, and the commercial outlook for companies developing diagnostics or treatments—much like spotting deep cracks in a building that require urgent repair.

esophageal adenocarcinoma medical

"high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC)"

Esophageal adenocarcinoma is a form of cancer that begins in the gland-like cells lining the lower part of the esophagus, the tube that carries food to the stomach. It matters to investors because it is often aggressive and has limited treatment options, so advances, trial results, regulatory approvals, or changes in insurance coverage for new tests and therapies can materially affect the prospects and valuations of companies working on diagnostics, drugs, or procedures—like a bridge repair changing traffic for nearby businesses.

endoscopic eradication therapy medical

"closer surveillance or endoscopic eradication therapy for patients"

Endoscopic eradication therapy is a group of minimally invasive procedures that use a flexible tube with a camera to locate and remove or destroy abnormal tissue lining the digestive tract, often to stop precancerous changes from progressing. For investors, it signals markets for specialized medical devices, procedure revenues and reimbursement trends, and clinical outcomes that can affect adoption—think of it as removing embers before a small fire becomes catastrophic.

risk stratification medical

"highlighting the need for more precise risk stratification"

Grouping people, projects or assets by their likelihood of a negative outcome—such as disease progression, regulatory problems, loan default or product failure—so decisions can be tailored to each group's risk level. Like sorting mail by urgency, risk stratification helps investors gauge which opportunities are safer or more speculative, adjust expected returns, prioritize resources, and estimate how likely different financial or regulatory outcomes are.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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FRIENDSWOOD, Texas, Sept. 28, 2026 /PRNewswire/ -- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today 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 (NDBE). 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 and is available here.

"All patients in this study had the same non-dysplastic Barrett's diagnosis, but TissueCypher showed that their risk of progression differed," said study author Caitlin C. Houghton, M.D., board-certified foregut surgeon at Keck Medicine of the University of Southern California (USC) in Los Angeles. "The test results helped us tailor management to each patient's individual risk — whether that meant closer surveillance or endoscopic eradication therapy for patients with intermediate- or high-risk results, or a longer surveillance interval for those with low-risk results. Ultimately, TissueCypher can help us detect patients at increased risk who may benefit from earlier surveillance or treatment and avoid unnecessary procedures for patients at lower risk."

Barrett's esophagus (BE) is a precancerous condition that can progress to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC). Patients with NDBE represent the majority of those undergoing surveillance for BE and are generally considered to have a low risk of progression. However, traditional clinicopathologic factors alone may not reliably distinguish the subset of patients with NDBE who are at elevated risk of progression, highlighting the need for more precise risk stratification. To assess TissueCypher's clinical utility in this population, the study evaluated 30 patients with NDBE who received testing as part of their clinical care at Keck Medical Center of USC.

Key Study Findings:

• TissueCypher identified higher-risk patients within NDBE: The test classified 17% of patients as intermediate or high risk for progression to HGD/EAC within five years and 83% of patients as low risk.
• Intermediate- or high-risk results supported escalated management: Management plans were escalated for all patients with intermediate- or high-risk TissueCypher results, including endoscopic eradication therapy for four patients and shorter-interval surveillance for one.
• Lower-risk results supported de-escalated management: Management was de-escalated for 84% of patients with low-risk TissueCypher results, including extending surveillance intervals or no longer recommending endoscopic eradication therapy.
• Test results changed management or increased confidence: TissueCypher results changed management recommendations or increased physicians' confidence in their plans for 97% of patients.

Findings from the study were also presented on Sept. 27 at the American College of Surgeons Clinical Congress 2026 in Washington, D.C.

Presentation details:

• Title: The Tissue Systems Pathology Test Impacts Clinician-recommended Management Decisions for Patients with Non-dysplastic Barrett's Esophagus
• Presenter: Katie M. Galvin, M.D., Keck School of Medicine of USC
• Session: QS101-1 | Quick-Shots I - Station 1: Bariatric/Foregut

About TissueCypher Barrett's Esophagus Test
TissueCypher is a precision medicine test designed and extensively validated to predict a patient's personalized risk of progression from Barrett's esophagus (BE) to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC). Indicated for patients with non-dysplastic BE, indefinite for dysplasia or with low-grade dysplasia, TissueCypher's five-year risk assessment is designed to help physicians tailor care to each patient's risk of developing HGD or EAC.

Backed by more than 17 peer-reviewed publications and studied in biopsies from more than 8,000 patients, TissueCypher has been shown to be the strongest independent predictor of progression compared with traditional histopathological risk assessment. Using an AI-derived spatialomics approach, the test identifies molecular signatures that often precede the development of dysplasia, which can enable earlier identification, treatment, and management of patients at increased risk of cancer. TissueCypher is designed to integrate seamlessly into routine endoscopic practice by analyzing standard esophageal pinch biopsies, delivering actionable insights without requiring additional procedures. Learn more at CastleBiosciences.com/TissueCypher.

About Castle Biosciences
Castle Biosciences (Nasdaq: CSTL) is a leading diagnostics company improving health through innovative tests that guide patient care. With a primary focus in dermatologic and gastroenterological disease, we develop personalized, clinically actionable solutions that help improve disease management and patient outcomes.

We put people first—empowering patients and clinicians and informing care decisions through rigorous science and advanced molecular tests that support more confident treatment planning. To learn more, visit www.CastleBiosciences.com and connect with us on LinkedIn, Instagram, Facebook and X. 

DecisionDx-Melanoma, DecisionDx-CMSeq, i31-SLNB, i31-ROR, DecisionDx-SCC, MyPath Melanoma, AdvanceAD-Tx, TissueCypher, Esopredict, 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: TissueCypher's ability to (i) predict a patient's personalized risk of progression from Barrett's esophagus to high-grade dysplasia or esophageal adenocarcinoma, (ii) help clinicians tailor surveillance and management decisions to each patient's individual risk profile, (iii) enable earlier identification and management of patients at increased risk of cancer, and (iv) help reduce uncertainty for patients. The words "believe," "can," "may" 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 "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2025, and our subsequent Quarterly Reports on Form 10-Q, each as filed or to be 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
czuckero@castlebiosciences.com

Media Contact:
Allison Marshall
amarshall@castlebiosciences.com

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SOURCE Castle Biosciences, Inc.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

How often did TissueCypher change management recommendations in Castle Biosciences' study?

TissueCypher results changed clinicians' management recommendations for 90% of the 30 patients studied. Results either changed recommendations or increased physicians' confidence in their plans for 97% of patients.

How did TissueCypher results affect care recommendations in Castle Biosciences' study?

Clinicians escalated management for every patient with an intermediate- or high-risk result. Four were recommended endoscopic eradication therapy, and one was recommended shorter-interval surveillance. Management was de-escalated for 84% of patients with low-risk results.

Where was Castle Biosciences' TissueCypher study published?

The study was published in Foregut: The Journal of the American Foregut Society. Its findings were also presented on Sept. 27 at the American College of Surgeons Clinical Congress 2026 in Washington, D.C.