Signatera™ – Residual Disease Test (MRD)

Casandra

Casandra Test Code NA10016Version 1 (DRAFT)

Performing Lab

Lab NateraLab Test ID N/A

Signatera™ – Residual Disease Test (MRD)

Clinical Use

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. ([natera.com](https://www.natera.com/oncology/billing/?utm_source=openai))

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. ([natera.com](https://www.natera.com/oncology/signatera-advanced-cancer-detection/?utm_source=openai))

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. ([natera.com](https://www.natera.com/oncology/signatera-advanced-cancer-detection/faq/?utm_source=openai))

Test Details