Signatera

Cancer monitoring through personalized tumor profiling

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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.

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.

Now it is possible to detect cancer recurrence earlier than before.

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

Does your immunotherapy work?

Signatera can be used to help you better manage your cancer treatment through a personalized approach that is as unique as yours.

If you are being treated with immune checkpoint inhibitors (ICIs), a type of immunotherapy, you may be wondering if the treatment works for you.

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.

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.

Optimizat pentru monitorizare longitudinală

Odată ce testul personalizat al pacientului a fost conceput, este necesară doar o probă de sânge de fiecare dată când Signatera^TM este comandat pentru tratamentul adjuvant sau programul de monitorizare.

Knowing earlier matters!

Each person’s cancer is as unique as their fingerprint. Signatera is a MRD 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 very real for many patients previously diagnosed with cancer. Living scan to scan creates anxiety and fearful thoughts: is the cancer coming back? Through shared decision making, many patients are working closely with their doctors to incorporate Signatera into their treatment plan to provide additional information needed for confident decision making and to provide patients peace of mind between scans. Patient anxiety may be alleviated by gaining a greater understanding of their progress and feel more informed on how they apporach their treatment options.

Signatera is validated in multiple cancer types: colorectal, breast, lung and prostate.

Why Signatera?

Signatera is a blood MRD test used for cancer detection and surveillance. It is personalized for each patient. It is used for molecular residual disease assessment and for treatment response monitoring.

A doctor may order Signatera along with routine follow-up exams to determine whether:

There are signs of cancer remaining in the body
Treatment (e.g., chemotherapy, radiation) is working
The cancer is recurring

Understanding Signatera test results

The test results will either be positive or negative for the presence of tumor DNA in blood. The doctor will receive the test report and will be able to discuss the results and answer questions. These results provide additional insights and may help guide the treatment plan.

IMPORTANT: Negative ctDNA results may change over time. A negative MRD test result doesn’t guarantee that cancer will never be detected in the future. This is why ongoing monitoring with the Signatera test, as directed by your doctor, is recommended—for early detection of residual disease.

Negative result

A negative result indicates that tumor DNA was not detected in your blood and that you are more likely to remain cancer-free if you were diagnosed with early stage cancer.
If you have metastatic cancer, a negative result may mean that your treatment was able to decrease the amount of cancer cells to undetectable levels, meaning the treatment has been effective.

Positive result

A positive result indicates that tumor DNA has been detected in your blood and means there is higher risk for your cancer returning if you were diagnosed with early-stage cancer. Your doctor may continue to monitor your ctDNA levels to assess your tumor’s response to treatment.

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.}