Castle Biosciences' TissueCypher Test Surpasses 100,000 Orders, Advancing Precision Risk Assessment for Barrett's Esophagus
核心洞察
Castle Biosciences (搜索) announced its TissueCypher (搜索) Barrett's Esophagus (搜索) Test has surpassed 100,000 clinical test orders, reflecting growing adoption of AI-derived precision risk assessment.
TissueCypher (搜索) predicts a patient's five-year risk of progression from Barrett's esophagus (搜索) to high-grade dysplasia (搜索) or esophageal adenocarcinoma (搜索), the only known precursor to this gastrointestinal cancer.
The test is backed by more than 17 peer-reviewed publications and studied in biopsies from over 8,000 patients, shown to be the strongest independent predictor of progression versus traditional histopathology.
Castle Biosciences (搜索), Inc. (Nasdaq: CSTL) announced that its TissueCypher (搜索) Barrett's Esophagus (搜索) Test has surpassed 100,000 clinical test orders, marking a significant milestone in the adoption of precision risk assessment for patients with Barrett's esophagus (BE). TissueCypher is an AI-derived precision medicine test designed to predict a patient's five-year risk of progression from BE to high-grade dysplasia (搜索) (HGD) or esophageal adenocarcinoma (搜索) (EAC).
"Barrett's esophagus (搜索) (BE) is the only known precursor to esophageal adenocarcinoma (搜索) (EAC), a gastrointestinal cancer associated with poor survival outcomes," said Emmanuel Gorospe, M.D., MPH, FACG, FASGE, board-certified gastroenterologist and medical director at Castle Biosciences (搜索). "TissueCypher (搜索) provides clinically validated risk stratification for patients with BE by identifying those at increased risk of progression to high-grade dysplasia (搜索) or EAC. It can help clinicians tailor management decisions based on an individual patient's risk profile, including consideration of intensified surveillance or endoscopic eradication therapy for high-risk patients and appropriate routine surveillance for low-risk patients."
Reaching the 100,000-order threshold reflects the growing use of TissueCypher (搜索) to deliver more personalized information about progression risk. "We are grateful to the clinicians who have incorporated TissueCypher into the management of patients with Barrett's esophagus (搜索) and to the patients who continue to advocate for more informed approaches to their care," said Toby Juvenal, chief commercial officer of Castle Biosciences (搜索).
For some patients, understanding their risk of progression may help reduce uncertainty after diagnosis. Robin Byrd Wilfong, a patient diagnosed with BE, received a low-risk TissueCypher (搜索) result indicating a 2% chance of progression over five years. "I don't feel like a ticking time bomb," she said. "I feel like I've got time to manage this the way I choose."
Clinical Validation and Technology
TissueCypher (搜索) is indicated for patients with non-dysplastic BE, indefinite for dysplasia, or with low-grade dysplasia. The test'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 (搜索) is designed to integrate seamlessly into routine endoscopic practice by analyzing standard esophageal pinch biopsies, delivering actionable insights without requiring additional procedures.
Commercial Trajectory and Market Adoption
TissueCypher (搜索) remains early in its commercial expansion, with approximately 15% patient penetration and significant room for growth. The test is additive to existing GI risk stratification, identifying at-risk Barrett's esophagus (搜索) patients who may benefit from more intensive surveillance or intervention. Expansion of the sales force and inclusion in two of three major GI society guidelines are expected to support further penetration.
Medicare patients make up less than half of the test volume, with commercial penetration still developing; broader adoption is expected to drive payer coverage. Castle Biosciences (搜索) is a diagnostics company with a primary focus in dermatologic and gastroenterological disease, developing personalized, clinically actionable solutions to improve disease management and patient outcomes.