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Model Signatera - Transforming the Management of Cancer with Personalized Testing
Signatera is a personalized, tumor-informed assay optimized to detect circulating tumor DNA (ctDNA) for molecular residual disease (MRD) assessment and recurrence monitoring for patients previously diagnosed with cancer, with broad utility for cancer management.
Detect residual disease early.
Treat with confidence.
Highly accurate 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.
Signatera has significant predictive value for long-term patient outcomes
The only significant risk factor in stage II-III colorectal cancer5-8
In multivariate statistical analysis, MRD status as measured by Signatera was the only significant predictor of long-term cancer patient outcomes, after adjusting for all known clinicopathological risk factors including disease stage and lymph node status.1
Learn what was discovered at our satellite symposia at ESMO GI 2021
Natera presented updated results from CIRCULATE-Japan clinical trial at ESMO GI, where Signatera was performed preoperatively and then serially after surgery. Findings include:
- MRD-negative patients had recurrence-free survival >99% at six months of follow-up, across all stages and regardless of whether adjuvant treatment was administered
- Pre-operative ctDNA was detected in 96% of patients with Stage II–III colorectal cancer
- Longitudinal ctDNA positivity was significantly associated with inferior DFS (HR=46.8)
- A relapse sensitivity of 93.1% was demonstrated – the highest seen in the longitudinal setting
When to use Signatera?
Adjuvant setting
Use Signatera after surgery to evaluate the need for adjuvant chemotherapy
Personalize and help inform when to reduce treatment
Surveillance setting
Assess for MRD more accurately than current risk-assessment methods
Use Signatera alongside CEA to detect recurrence earlier while it may still be resectable, or to reduce false positive CEA results
Utilizing the Signatera test, early detection of MRD has become a powerful tool for improving cancer management outcomes.
- MRD measures ctDNA, a type of cell-free DNA that can be detected and measured in the body’s circulatory system.
- Accurate identification and quantification of ctDNA in the body can be used to indicate that there are cancer cells present, even after treatment.
- MRD detection with Signatera is different from traditional uses of ctDNA (therapy selection, asymptomatic cancer screening), because it uses a personalized genetic test, informed by the patient’s own tumor mutation signature.
Signatera helps you dive deeper
Detect residual disease early. Treat with confidence.
Adjuvant setting
- Use Signatera after surgery to evaluate the need for adjuvant chemotherapy
- Personalize and help inform when to reduce treatment
Surveillance setting
- Assess for MRD more accurately than current risk-assessment methods
- Use Signatera alongside CEA to detect recurrence earlier while it may still be resectable, or to reduce false positive CEA results
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
Knowing earlier matters
Each person’s cancer is as unique as their fingerprint. Signatera is a new blood test that is personalized to each patient’s set of tumor mutations and can identify earlier than traditional tools if cancer is still present. Knowing this information can help you have a more informed discussion with your doctor regarding your treatment journey.
How Signatera helps patients through their treatment
Scanxiety is often echoed during patient conferences, forums, and on social media. Living scan to scan creates a situation where patients are unable to make plans outside of months or even weeks. Why let indeterminate scans and unclear biomarkers like CEA be the barrier? Through shared decision making, many patients are working closely with their doctors to incorporate Signatera into their plan to provide additional information needed for confident decision making and to provide patients peace of mind between scans.