The purpose of the test is to determine if there are any residual tumour cells in the body. The genetic defect that caused tumour formation, is currently not under investigation during the test.
Tumour markers are biochemicals that are selectively produced by tumour cells and can be detected in the blood or other body fluids. Tumour markers are not the most suitable agents for screening due to their sensitivity, they are only confirmatory in themselves, as their accuracy is much lower compared to that of the Signatera test. Therefore, the results of a Signatera test may not be reproducable by a tumour marker test.
After the operation, it is recommended to wait about 3-4 weeks for taking the first blood sample. In this way, we can reduce the disruptive effect of tumour cells entering the bloodstream during surgery, as the genetic information from circulating tumour cells degrades in 3-4 weeks, so it will no longer affect the result.
Modern imaging tool exams (CT, MR, PET-CT) are based on a resolution of approximately below 4-5 mm, they cannot accurately separate the abnormal tissue part from the healthy one. In contrast, the Signatera test, due to its sensitivity, will give a positive result for the few circulating tumour cells. During Signatera case studies, a case has been described where Signatera indicated recurrent tumour 2 years prior to detection by monitoring tool procedures.
It is important that the first blood sample is taken 3-4 weeks after surgery. If you want to use the Signatera test to follow your therapy, you will need to take the test 2-3 weeks after finishing your current treatment, before the next treatment. The dates for the follow-up are unique for every individual and tumour, therefore a consultation is required to establish them.In case of a positive result, it is recommended to repeat the sampling within 3-6 months. In case of a negative result, it is advisable to take another measurement after 3 months, if it is also negative, then the sampling plan can be changed depending on the tumour type (increase the sampling window for up to 10-12 months).
For haematological malignancies, the test is not performed for several reasons. On one hand, several well-functioning tests are available for these diseases, those similarly examine RD (residual tumour). On the other hand, blood-based diagnostics for Signatera do not work technologically if the components in the blood are damaged.
A tissue block is a piece of tissue embedded in paraffin. Any tissue removed during surgery or a thick needle biopsy will be processed in the pathology of the hospital. The final histological diagnosis is determined as to whether we are dealing with a benign or malignant tumour and which cell or tissue layer it originates from. This block must be kept by the hospital for 30 years from the date of processing. Various molecular tests can be performed later on, so this is also required for the Signatera test. Before this sample enters the laboratory, a pathologist checks certain parameters to see if the sample is really suitable for genetic testing.
It is not yet available. A particular diagnostic test takes a long time to be accepted for funding. In such cases, there is an opporturnity for individual applications to be submitted.
Currently available molecular pathology tests and the Signatera test can help cancer patients in different ways. The Signatera test can be effective in predicting whether there is a tumour in the body or how effective the current treatment is for patients who are at an early stage or who have already recovered and for patients who need follow-up. In contrast to other exams that look for gene defects that cause tumour formation, to be able to recommend different therapies. This direction is more common in metastatic patients. The two tests can even complement each other, so it may also be possible to have both tests done for anyone who needs it.
The test uses whole exom sequencing (WES) technology. This means that it examines the information-carrying regions of all (about 20,000) of our genes in a single test. Thus, it differs from other genetic tests in that they usually analyse only one or a few genes at a time.
The results of the first sent samples will be ready in 6-8 weeks. During this time, the patient-specific mutation pattern from the tumour and blood is determined. They make a comparison and use this information to determine the presence or absence of circulating tumour DNA. It takes 2 weeks to analyze each additional blood sample.
For available test packages and prices, visit the following page: Signatera packages and prices
Oncologists are informed about the test in various forums such as congresses, personal meetings, newsletters.
The Signatera test shows the direction of whether it is necessary to start / change treatment or whether the current therapy is effective. Exactly what kind of treatment a patient should receive depends on the decision of their doctor. Regarding the results, it is important to know if a treatment needs to be started just in time.
Signatera is not suitable for hereditary tumours because the test does not examine the type of tumour that is present in the patient's body. The test examines if the tumour is present or not.
Yes, it can be used because we can monitor the effect of the treatment with the help of the test.
In the treatment protocols, a Signatera result is not yet recorded. It is up to the treating physician and the patient to decide whether to start a treatment based on the positive result.
There is no private oncology department yet, but specialist appointments are already available in this form.
It is an alternative method of tumour treatment based on the death of certain tumour cells due to high temperatures. In Hungary, localhyperthermia has been allowed in special centers since 2005. We, as a diagnostic laboratory, cannot give an opinion on a therapeutic procedure, we undertake to perform the diagnostics.
The test can be performed on all solid tumours, regardless of stage. A solid tumour is simply a tumour that does not originate from “bloodcells”. It can be said, that this definition is true for almost all type of tumours other than hematological tumours. So there is a wide palette where Signatera can be applied.
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