SIGNATERA - pierwszy test- projektowanie sygnatur

Signatera is a tool for the effective monitoring of immunotherapy. It is a highly sensitive and personalised test for molecular residual disease (MRD) using circulating tumour DNA (ctDNA), designed specifically for each patient to help identify recurrence earlier. Signatera is a tumour-informed approach, clinically validated across many tumour types and proven across all phases of treatment. Signatera makes it possible to identify patients who are not responding to immunotherapy, as well as patients with a durable response who have achieved lasting clinical benefit from immunotherapy.

Use the Signatera test after surgery to assess the need for adjuvant chemotherapy and potentially avoid unnecessary treatment.

Developed by the American company Natera, the test has been granted Breakthrough Therapy designation by the FDA. 

The test is performed by Natera in the United States.

METHODOLOGY

In the first stage of the test, an individual set of so-called tumour "signatures" of the given patient's mutations is created. This is determined by a one-time analysis of the patient's blood and tumour tissue.

To create the signatures, a paraffin block with tumour tissue, a slide with stained material, and 3 tubes of the patient's blood are required (one tube with 6 ml of whole blood in EDTA and 2 Streck-type tubes with 10 ml of blood each).

How does Signatera differ from current biomarker tests?

Unlike other ctDNA tests, Signatera is intended for the accurate detection of MRD (i.e. it is not intended for early cancer screening or for identifying actionable mutations for therapy selection). Instead, Signatera is tailored to each patient's unique tumour signature in order to optimise sensitivity and specificity for an accurate assessment of MRD.

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 lower likelihood of response to the current treatment. A decrease in ctDNA levels indicates that the tumour may be responding to the current immunotherapy, which has been shown to be associated with favourable outcomes.

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

TURNAROUND TIME

For the first order, designing the personalised Signatera test will take 4 weeks from delivery of the material to the laboratory in the USA.