Clinical applications of ctDNA testing for MRD assessment
Now it is possible to detect cancer recurrence earlier than before
Georges Azzi, MD
Oncologist at Holy Cross Health, Ft. Lauderdale, FL
Signatera™ is the first tumor-specific assay for truly individualized cancer care
Personalized design for every patient
- Custom-built assay—based on the unique mutation signature of each patient’s tumor—identifies and tracks tumor mutations at the source
- Once a personalized assay is designed, a patient’s blood can be used to accurately monitor for the presence or absence of the disease over time
A positive Signatera™ result predicts relapse with overall positive predictive value more than 98%1-4
In clinical studies, Signatera showed high performance across multiple solid tumors
88% sensitivity to relapse
Average lead time 8.7 mos
89% sensitivity to relapse
Average lead time 9.5 mos
92% sensitivity to relapse
Average lead time 4.0 mos
100% sensitivity to relapse
Average lead time 2.8 mos
Signatera is widely validated
Detect residual disease early.
Treat with confidence.
MRD testing uniquely personalized to each patient’s tumor mutation signature
- Highly sensitive non-invasive assay to detect MRD earlier than other standard of care clinical tools.1‑4
- Earlier cancer recurrence monitoring to help inform adjuvant treatment decisions.
- Custom-built for each patient, using tumor tissue from surgical resection.
- Highest level of monitoring accuracy when determining whether to augment or reduce therapy.
How Signatera™ Works: a personalized and tumor informed approach to MRD surveillance
Personalized, tumor-informed assay
One-time, primary tissue sample and matched normal tissue is required for whole exome sequencing and personalized test design.
Ultrasensitive ctDNA detection
Signatera™ is designed to detect ctDNA of somatic and truncal variants to optimize sensitivity. Tumor-informed method enables filtering of CHIP mutations to decrease false positive rates.
Optimized for longitudinal monitoring
Once the patient’s personalized test has been designed, only a blood sample is needed each subsequent time.
To get started, send in your Signatera™ requisition form, sign in to the online portal or talk to your sales representative.
Send tumor block or slides to prepare the personalized tumor-informed assay
Complete information on tube labels
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