Signatera™ – Residual Disease Test (MRD)
Use
Signatera™ is a personalized, tumor‑informed molecular residual disease (MRD) assay using circulating tumor DNA (ctDNA), custom‑designed for each patient to detect recurrence earlier than conventional methods and monitor treatment response across multiple solid tumor types. It supports risk stratification, detection of recurrence, and therapeutic response monitoring, with demonstrated high sensitivity and positive predictive value in clinical studies. Once the assay is designed, only a blood sample is needed for longitudinal monitoring of ctDNA levels, enabling early detection of relapse and guidance of treatment decisions.
Special Instructions
Initial test design requires a primary tissue sample and matched normal sample (e.g., tumor tissue block or slides and blood) for personalized assay development. Subsequent testing requires only blood draws. The test is tumor‑informed and filters out CHIP mutations to reduce false positives.
Limitations
Signatera™ is not intended for early cancer screening nor for identifying actionable mutations for therapy selection. A negative result does not guarantee future absence of disease; ongoing monitoring is recommended. The test design depends on availability of tumor tissue and matched normal samples.
Methodology
NGS (WES)
Biomarkers
Result Turnaround Time
7-10 days
Related Documents
For more information, please review the documents below
Tumor Tissue (FFPE)
Tumor Profiling (WES)
Volume
Not provided
Minimum Volume
Not provided
Collection Instructions
Primary tumor tissue provided as FFPE block or slides (core biopsy tissue acceptable; no FNA)
Other tests from different labs that may be relevant