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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.

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Molecular residual disease is different

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.
Uses of ctDNA testing Signatera

Now it is possible to detect cancer recurrence earlier than before

“Tumor-informed circulating tumor DNA tests have broad clinical utility across cancer types. I am excited to partner with Natera to further explore early indications of treatment response, or lack thereof, using this novel technology.”
Georges Azzi, MD

Georges Azzi, MD

Oncologist at Holy Cross Health, Ft. Lauderdale, FL

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
FDA quote

Signatera achieved Breakthrough Device designation by the U.S. Food and Drug Administration, a recognition given to equipment that offers innovative technology and/or significant advantages over existing alternatives.

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
Signatera Graphics-colon
Signatera Graphics-breast
Signatera Graphics-Lung
Signatera Graphics-Bladder

Find out more about the Signatera test for MRD

View All Resources
About Signatera and ctDNA
About Signatera and ctDNA
Watch Video
Oncology Signatera Video
The Signatera Approach
The Signatera Approach
Watch Video
Oncology Signatera Video
Seeing beyond the limit: Detect residual disease and assess treatment response
Summary of analytical and clinical data for Signatera™, the first ctDNA assay custom-built for MRD detection and treatment response.
Read Document
Oncology Signatera Whitepaper

Is Signatera right for you?

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References

1Reinert T, Henriksen TV, Christensen E, et al. Analysis of Plasma Cell-Free DNA by Ultradeep Sequencing in Patients With Stage I to III Colorectal Cancer. JAMA Oncology. 2019;5(8):1124-1131.

2Coombes C, Page K, Salari R, et al. Personalized Detection of Circulating Tumor DNA Antedates Breast Cancer Metastatic Recurrence. Clinical Cancer Research. 2019;25(14):4255-4263.

3Abbosh C, Birkbak N, Wilson GA, et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017,545:446–451

4Christensen E, Birkenkamp-Demtröder K, Sethi H, et al. Early Detection of Metastatic Relapse and Monitoring of Therapeutic Efficacy by Ultra-Deep Sequencing of Plasma Cell-Free DNA in Patients with Urothelial Bladder Carcinoma. 2019; 37(18):1547-1557.