Signatera™ for Biliary Tract Cancer

Signatera™ is setting the standard for MRD testing in biliary tract cancer. Each assay is custom-designed to detect molecular residual disease earlier than standard biomarkers like CA19-9 and CEA, giving you actionable insight to guide post-surgical risk stratification and treatment decisions.

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Inform clinical challenges in biliary tract cancer

Identify high-risk patients

50 – 70%

of patients relapse within 1-2 years after curative resection, often with distant or unresectable disease.¹

Risk stratify

94%

of Signatera™-positive patients during surveillance went on to recur, an 18x higher risk than Signatera™-negative patients.¹

Catch recurrence sooner

3.7

months was the median lead time Signatera™ detected recurrence ahead of imaging.¹

Use Signatera™ to identify patients at the highest risk of disease progression post-surgery

Post-Operative MRD (2–12 Weeks Post-Surgery)

Signatera™-positive patients were 9x more likely to recur and 5x more likely to die¹
1-year RFS of 13% vs 75%
1-year OS of 56% vs 96%

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Signatera™ detected molecular relapse before radiographic progression

Post-Definitive Treatment Surveillance

4% of Signatera -positive patients went on to recur¹
18x higher risk than negative patients
Detected a median of 3.7 months ahead of imaging
1-year RFS 32% vs 92%
1-year OS of 85% vs 98%

Signatera™ status was prognostic of clinical outcomes at MRD and surveillance windows but common biomarkers such as CA19-9 and CEA were not

^{statistically significant p values less than (p < 0.001)}

Clinical questions Signatera™ may help answer in biliary cancer

Is Signatera™ for bile duct cancer right for your patients?

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References

¹Malla M, Esmail A, Tin A, et al. Real-world analysis of ctDNA and other biomarkers in patients with curatively resected stage I-III biliary tract cancer. ESMO Gastrointest Oncol. 2026;13(PB):100344. doi:10.1016/j.esmogo.2026.100344

²Yoo C, et al. Circulating tumor DNA status and dynamics predict recurrence in patients with resected extrahepatic cholang iocarcinoma. J Hepatol. 2025;82(5):861-870. doi:10.1016/j.jhep.2024.10.043