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Systematic Review and Meta-Analysis Confirms TissueCypher® Outperforms Traditional Pathology or Clinical Factors Alone to Identify Patients at Increased Risk of Developing Esophageal Cancer

1. TissueCypher test shows improved risk stratification for Barrett’s esophagus patients. 2. Study confirms TissueCypher outperforms traditional methods in identifying cancer risk. 3. Key findings indicate high-risk patients are 6.7 times more likely to progress. 4. TissueCypher aids personalized care, supporting earlier interventions and reducing unnecessary procedures. 5. The test uses AI-driven spatialomics for precise patient management.

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FAQ

Why Very Bullish?

The validation of TissueCypher enhances CSTL’s market position and potential revenue growth. Historically, advancements in diagnostic tests have led to significant stock price increases in similar companies.

How important is it?

The publication of the SRMA elevates TissueCypher’s credibility, likely leading to increased adoption and sales impact for CSTL.

Why Long Term?

Impact will be realized as demand for cancer risk stratification tests grows, enhancing CSTL’s portfolio value over time.

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Castle Biosciences' TissueCypher® Test Demonstrates Enhanced Risk Stratification for Esophageal Cancer

FRIENDSWOOD, Texas, Dec. 12, 2025 (GLOBE NEWSWIRE) — Castle Biosciences, Inc. (Nasdaq: CSTL) has announced pivotal findings from a systematic review and meta-analysis highlighting the effectiveness of its TissueCypher® Barrett’s Esophagus (BE) test in identifying patients at increased risk of developing esophageal cancer. This breakthrough offers a promising alternative to traditional pathology methods.

Summary of Study Findings

The systematic review and meta-analysis (SRMA), titled “The Tissue Systems Pathology Test Predicts Risk of Progression in Patients With Barrett’s Esophagus: Systematic Review and Meta-Analysis,” was published in the Journal of Clinical Gastroenterology. It consolidates data from six studies, confirming that TissueCypher consistently shows superior capability in identifying patients who may progress to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC).

According to Castle Biosciences, the analysis emphasizes the need for personalized patient management strategies aimed at cancer prevention, leveraging TissueCypher's results for effective risk assessment.

Key Insights from the Research

Dr. Caitlin C. Houghton, the lead author and a board-certified foregut surgeon at Keck Medicine of USC, emphasized the significance of the findings:

“Our findings provide strong evidence that TissueCypher delivers meaningful risk stratification for patients with Barrett’s esophagus. By identifying which patients are truly at high risk for progression to esophageal cancer — and which are not — TissueCypher can help physicians personalize care, flagging those who may benefit from earlier intervention.”

Performance Metrics of TissueCypher

  • Identifying High-Risk Patients: Patients with high-risk TissueCypher results were found to be 6.7 times more likely to progress to HGD or EAC within five years compared to low-risk results (p<0.0001).
  • Confidence in Care: The annual progression rate for patients with high-risk results was 5.6%, significantly higher than the 1.7% rate often seen in low-grade dysplasia, indicating potential for earlier intervention.

About the TissueCypher Test

TissueCypher is a precision medicine test specifically designed to assess a patient's risk of progression from Barrett’s esophagus to HGD or EAC. It targets patients with non-dysplastic BE, indefinite for dysplasia, or low-grade dysplasia through a five-year risk assessment framework. Backed by extensive research, including 17 peer-reviewed publications and analysis of over 8,000 patient biopsies, the test has proven to be the strongest independent predictor of disease progression.

Utilizing an AI-driven spatialomics approach, TissueCypher detects molecular signatures that indicate heightened risk of dysplasia, enabling clinicians to act more swiftly and effectively to manage patient care.

About Castle Biosciences

Castle Biosciences (Nasdaq: CSTL) is committed to enhancing health outcomes through innovative diagnostic tests. Their focus spans various diseases, primarily in dermatologic and gastroenterological fields, creating personalized solutions that empower patients and clinicians alike.

For further information on TissueCypher and other diagnostic tools, visit Castle Biosciences' official website.

Forward-Looking Statements: This press release may contain forward-looking statements that are subject to risks and uncertainties. Actual outcomes may differ, and readers should not place undue reliance on these statements.

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