SIGNATERA - monitorujące badanie kontrolne

Use the Signatera monitoring test to find out as early as possible whether the therapy you are receiving is effective. The test makes it possible to monitor the status of the disease and the response to treatment. It can only be performed after the first test, which is the design of the signatures.

Signatera is a test for monitoring tumour progression, created for patients who are currently receiving, or are considering, chemotherapy and immunotherapy. The aim of the test is to monitor the patient's molecular residual disease (MRD). MRD is the presence in the blood of tiny traces of the tumour, such as ctDNA or microscopic fragments of tumour DNA. Changes in MRD are visible long before any changes appear on imaging tests.

Signatera is an approach based on the individual tumour profile of each patient, with clinically validated effectiveness in monitoring many tumour types and across all phases of treatment. Signatera makes it possible to identify patients who are not responding to the treatment used, as well as patients with a durable response who have achieved lasting clinical benefit from the therapy used.

The test is performed by Natera in the United States.

METHODOLOGY

Two 10-millilitre Streck-type tubes of the patient's blood are required to perform the monitoring test.

Monitoring with the Signatera test gives us knowledge that helps answer critical questions: 

• Is any tumour remaining in the body?
• Will additional treatment be necessary?
• Is the current treatment working?

What do the test results mean?

A positive Signatera result means that tumour ctDNA has been detected in the blood. 

A rise in ctDNA levels indicates a reduced or absent response to the current treatment. A decrease in ctDNA levels indicates that the tumour may be responding to the therapy currently being used, which has been shown to be associated with favourable treatment outcomes.

A negative Signatera result means that no tumour ctDNA has been detected in the blood, and the clinical data indicate that in such a situation there is a high likelihood of a favourable or complete response to therapy.

TURNAROUND TIME

The results of the monitoring test will be available within 2–4 weeks of delivery of the material to the laboratory in the USA.