Personalized Test for Cancer Monitoring
Signatera™ from Natera is a personalized and highly sensitive blood test that analyzes circulating tumor DNA (ctDNA) to detect minimal residual disease (MRD) and monitor response to treatment and the risk of cancer recurrence.
Unlike standard biomarker tests, Signatera™ is individually developed for each patient using the unique genetic profile of their tumor.
What is MRD?
MRD – Molecular Residual Disease refers to the presence of a very small amount of tumor cells or tumor DNA that may remain in the body after treatment, even when it is not visible with standard imaging methods.
Signatera™ looks for traces of tumor DNA in the blood to help the physician assess whether there is molecular evidence of disease.
How does Signatera work?
Signatera is a tumor-informed test, meaning that the test is personalized based on the genetic characteristics of the patient’s tumor. Step 1 – Tumor analysis
A sample of tumor tissue is obtained, usually from material preserved after a biopsy or surgical procedure.
The genetic alterations characteristic of the tumor are identified. Step 2 – The personalized test is created
Based on these alterations, a personalized test is created that is specific to the patient’s tumor. Step 3 – Blood sample
A blood sample is then collected and analyzed for the presence of ctDNA, meaning fragments of DNA originating from the tumor. Step 4 – Monitoring over time
The test can be repeated during treatment and follow-up to determine whether tumor DNA:
This makes Signatera™ particularly suitable for serial monitoring according to the plan determined by the physician.
What is ctDNA?
ctDNA (circulating tumor DNA) consists of fragments of DNA released by tumor cells that may be found in the bloodstream.
Signatera™ looks for ctDNA that matches the unique profile of the patient’s tumor.
This distinguishes it from tests that measure only general cancer markers.
What is Signatera™ used for?
Signatera™ may be used at several different points throughout a patient’s cancer journey. 1. After surgery
It may help assess whether there is molecular evidence of residual disease after the procedure. 2. During or after treatment
It may be used to monitor changes in ctDNA and provide additional information about the response to treatment. 3. During follow-up
It may be used for repeated monitoring to identify molecular signs that may be associated with disease recurrence. 4. During immunotherapy
Signatera™ may be used as an additional tool to monitor changes in ctDNA during immunotherapy.
What can the result indicate?
Negative result
A negative result means that tumor ctDNA was not detected in the blood sample at that time.
In patients with early-stage disease, a negative result may be associated with a lower risk of recurrence compared with patients with detectable ctDNA.
However, a negative result does not guarantee that the cancer will not recur and does not completely rule out the presence of disease. For this reason, repeated monitoring may be important.
Positive result
A positive result means that tumor DNA was detected in the blood.
In the context of MRD, this may indicate the presence of molecular residual disease and may be associated with a higher risk of recurrence in patients with early-stage cancer.
The result should always be interpreted by the physician together with imaging, clinical history, and other test results.
Does Signatera™ replace CT, MRI, or PET/CT?
No.
Signatera™ is an additional tool for molecular disease monitoring and does not replace imaging examinations, laboratory tests, clinical examination, or other standard follow-up methods.
Signatera™ results should be interpreted together with all of the patient’s clinical data.
What types of cancer is it used for?
Signatera™ may be used for a wide range of cancers, depending on the clinical situation and the purpose of testing.
Natera lists uses including:
Use and interpretation depend on the type of cancer and the patient’s specific situation.
What type of sample is required?
For the initial development of the personalized Signatera™ test, tumor tissue is required.
Subsequently, monitoring is performed using blood samples.
For initial testing, Natera requires FFPE tumor tissue or slides, together with the corresponding blood samples.
How long does it take to receive the results?
For the initial test, development of the personalized test usually takes 3–4 weeks after the tumor and blood samples are received.
Follow-up blood tests typically have a turnaround time of 7–10 days. How often is Signatera performed?
The frequency is determined by the physician depending on:
In some cases, Signatera™ is performed regularly, often at intervals of approximately 3 months, but the protocol
It is a personalized, tumor-informed blood test that analyzes ctDNA to assess minimal residual disease and monitor cancer.
It is a molecular test of tumor DNA, but it is not a test for inherited genetic predisposition such as Empower™.
Signatera™ monitoring is performed using blood, but tumor material is also required to initially create the personalized test.
Yes. Signatera™ may be used after surgery to assess MRD and during follow-up, according to the physician’s plan.
Changes in ctDNA levels over time may provide the physician with additional information about the response to treatment.
It means that tumor ctDNA was not detected in that blood sample. It does not guarantee that the cancer will not recur.
It means that tumor ctDNA was detected. In the context of MRD, this may indicate molecular residual disease and a higher risk of recurrence, depending on the clinical situation.
No. It is an additional tool and should be used together with other monitoring methods.
The frequency is determined by the physician. In many cases, it may be performed periodically during follow-up.
The initial test usually takes approximately 3–4 weeks, while subsequent blood tests take approximately 7–10 days.
Yes. Altera™ and Signatera™ can be ordered using the same tumor sample.
No. A negative result indicates that ctDNA was not detected at that time and does not guarantee the future absence of disease. Continued monitoring may be necessary.
