Frequently Asked Questions (FAQ)

Will the Signatera™ test tell me which gene defect caused my tumour?

The purpose of the test is to determine whether there are any residual tumour cells in the body. Which gene defect caused the tumour to form is not currently being investigated.

What is the difference between the Signatera™ test and tumour marker tests?

Tumour markers are biochemical substances selectively produced by tumour cells that can be detected in the blood or other body fluids. Tumour markers are not the most suitable for screening because of their sensitivity, they are only confirmatory in themselves, as their accuracy is much lower than that of the Signatera test. So what the Signatera™ test detects, tumour marker tests may not be able to detect.

How long do I have to wait after the operation for the first blood sample (Signatera blood test)?

It is recommended that the first blood sample is taken about 3-4 weeks after the operation. This will reduce the confounding effect of tumour cells entering the bloodstream during surgery, as the genetic information from circulating tumour cells degrades in 3-4 weeks and does not affect the outcome.

What is the difference between the resolution of imaging tests and the Signatera™ test?

Modern imaging scans (CT, MR, PET-CT) cannot accurately distinguish abnormal tissue from healthy tissue at a resolution of less than 4-5 mm. In contrast, the Signatera™ test, due to its sensitivity, will give a positive result for as few as a few circulating tumour cells. Cases have been described where the Signatera™ test has detected recurrent tumours 2 years earlier than imaging.

What is the recommended interval for follow-up blood tests?

It is important that the first blood sample is taken 3-4 weeks after the operation. If you want to use the Signatera test to follow up your therapy, you should take the blood test 2-3 weeks after the treatment, before the next treatment. These follow-up timings are individual and tumour dependent, so prior consultation is necessary 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 repeat the measurement after 3 months, and if negative, the sampling plan can be changed depending on the tumour type (up to a 10-12 month sampling window).

Why is the test not suitable for haematological tumours?

In the case of haematological malignancies, the test is not performed for several reasons. Firstly, there are several well-established tests available for these diseases, which similarly test for MRD (residual residual tumour). On the other hand, diagnostics from blood for Signatera™ is technologically not feasible if the blood is damaged.

Is NEAK funding available for the Signatera™ test?

Not yet available. A particular diagnostic test takes a long time to be accepted for funding. In such cases, individual applications are possible.

What is the difference between the oncology tests currently on the market?

Currently available molecular pathology tests and the Signatera™ test can help tumour patients in different ways. The Signatera™ test can effectively predict whether there is a tumour in the body or how effective the current treatment is for patients who are in the early stages or who have been cured and need follow-up.

Unlike other studies, which look for the genetic defects that cause tumours to develop, so that different therapies can be proposed. This is more typical in metastatic patients.

The two tests can be complementary, so it is possible that someone who needs one can do both.

How many genes does the test look for?

The test uses whole exome sequencing (WES) technology. This means that in a single test, it examines the information-carrying regions of all (about 20,000) of our genes. So it differs from other genetic tests in that they usually analyse only one or a few genes at a time.

How long will it take to get my result?

The results of the first samples sent out will be available in 6-8 weeks. During this time, a patient-specific mutation pattern is determined from the tumour and blood.

These are compared and this information is used to determine the presence or absence of tumour DNA circulating in the blood. Each additional blood sample takes 2 weeks to analyse.

How are oncologists informed about the test?

Oncologists are informed about the test by our colleagues in various forums (congresses, face-to-face meetings, newsletters).

Can you suggest a therapy in the light of my results?

The Signatera™ test gives you a guide as to whether you need to start/change treatment or whether the current therapy is effective. Exactly what treatment the patient should receive is at the discretion of the treating physician, in our case the time factor is important to know if a particular treatment is needed.

Is the test suitable for hereditary cancers with a family history?

Hereditary tumours are not answered because the test does not look at what type of tumour is present in the patient’s body, but whether or not the tumour is still present.

Is the test suitable for inoperable tumours?

Yes, it can be used, because it allows us to monitor the effect of the treatment through the test.

If Signatera™ gives a positive result, will I receive treatment?

It is not yet fixed in the treatment protocols. It is up to the doctor and the patient to decide whether to start treatment in the light of a positive result.

Are private oncology services available in Hungary?

There is no private oncology department at the moment, but specialist services are already available.

What is the opinion about thermotherapy treatment?

It is an alternative method of tumour treatment based on the killing of certain tumour cells by high temperatures. In Hungary, local hyperthermia has been authorised in specialised centres since 2005. We as a diagnostic laboratory cannot give an opinion on a therapeutic procedure, we undertake to perform the diagnostics.

For which tumour types can the test be used?

The test can be performed in all solid tumours, regardless of stage. Simply put, a solid tumour is a tumour that does not originate from “blood cells”. It can be said that almost any tumour type other than haematological tumours fits the definition. Thus, there is a wide range where it can be applied.