SignateraTM

Transforming the management of cancer with personalized testing

Signatera is a highly sensitive and personalized molecular residual disease assay (MRD) using circulating tumor DNA (ctDNA), custom designed for each patient to help identify relapse earlier than standard of care tools.

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Uses of ctDNA testing

Signatera

Asymptomatic cancer screening

Molecular residual disease (MRD) status

Surveillance for early recurrence monitoring

Treatment response monitoring

Cancer therapy selection

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 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.

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
Oncologist at Holy Cross Health, Ft. Lauderdale, FL

“Detecting relapse before it becomes clinically symptomatic requires a test with high sensitivity and specificity. Signatera enables us to confidently identify patients with molecular relapse when the disease burden is so low that it is undetectable with imaging.”

Lajos Pusztai, MD, DPhil
Professor of Medicine (Medical Oncology); Co-Leader, Genetics, Genomics and Epigenetics Research Program, Yale Cancer Center, Yale School of Medicine

Reassurance

Finding reassurance with Signatera

After JoAnn was diagnosed with lung cancer, she learned how Signatera could help her doctor detect potential disease progression ahead of scans. As part of her cancer monitoring plan, she received Signatera testing at regular intervals, helping her and her doctor make critical decisions. Learn how Signatera helped JoAnn and her family stay confident and positive throughout her treatment journey.

"Signatera is a great warning system that something is going on. From there, you figure out what it is. Signatera does empower me to be my own best advocate with my oncologists."

JOANN
Living with lung cancer

Test

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

Results

Signatera is validated in multiple cancer types

I have colorectal cancer

If you have been diagnosed with colorectal cancer, learn more how to identify residual disease and detect relapse sooner with Signatera MRD testing

Colorectal cancer patient

I am on immunotherapy

If you are undergoing immunotherapy and want to know how the Signatera MRD test can help monitor the effectiveness of your treatment.

Immunotherapy patient

Is Signatera right for me?

If you have been diagnosed with cancer such as breast, ovarian, lung or melanoma and want to learn more how to identify residual disease and detect relapse sooner

Tudjon meg többet
How it works?

How Signatera works? a personalized and tumor informed approach to MRD surveillance

Signatera is a personalized and tumor informed approach to MRD surveillance

A one-time analysis of both blood and tissue determines your unique set of tumor mutations.

The MRD test is custom-built and personalized just for you, using your own tumor tissue.

Signatera MRD test detects small fragments of ctDNA each time it is ordered as part of your routine follow-up blood tests. Patients who are ctDNA positive by Signatera are more likely to relapse.

Signatera can help guide care for your cancer patients

Risk level

Actionable results: Stage II-III colorectal

Test interpretation

ctDNA High Risk

Consider directed imaging (PET/MRI) to locate the disease while potentially resectable

>97% of patients will relapse

ctDNA Reduced Risk

Continue monitoring with reassurance

12-14% patients may relapse. Patients who remain negative 2 years post treatment have risk reduced to 3%

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Is SignateraTM right for you?

We're here to help you find out!

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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.

The tests described have been developed and their performance characteristics determined by the CLIA-certified laboratory performing the test. The tests have not been cleared or approved by the US Food and Drug Administration (FDA). Although FDA is exercising enforcement discretion of premarket review and other regulations for laboratory-developed tests in the US, certification of the laboratory is required under CLIA to ensure the quality and validity of the tests. CAP accredited, ISO 13485 certified, and CLIA certified. © 2022 Natera, Inc. All Rights Reserved.