Signatera™ & Latitude

Nesiller provides Signatera™ solutions as Natera’s sole authorized distributor in Türkiye.

What Is a ctDNA Test?

Signatera™ is a highly sensitive, tumor-informed Minimal Residual Disease (MRD) test. By analyzing circulating tumor DNA (ctDNA) in the blood, it helps identify the risk of recurrence at an early stage, monitor treatment response, and support clinical decision-making. The Signatera™ test is performed at Natera laboratories in the United States. It is an FDA-approved MRD test and is recommended by international guidelines for several tumor types, including colorectal cancer, breast cancer, and non-small cell lung cancer.

A positive Signatera™ result indicates that traces of tumor-derived DNA have been detected in the blood. In other words, it indicates an increased risk of disease recurrence, as demonstrated in studies such as IMvigor and GALAXY. A negative Signatera™ result means that no traces of tumor-derived DNA were detected in the blood at the time of testing. However, a negative result does not mean that the disease will not recur in the future. Therefore, depending on the physician’s assessment, repeat Signatera™ testing at regular intervals, typically every 3–6 months, may be recommended.

In MRD testing, the tumor-informed approach uses the genetic alterations specific to a patient’s own tumor to provide personalized results. Other MRD tests, known as tumor-naive tests and performed using blood samples without first establishing a personalized tumor profile, may offer more limited sensitivity compared with the tumor-informed approach.

What Questions Can Signatera™ Help Address?

• Assessment of treatment response during the neoadjuvant period

• Evaluation of the need for adjuvant therapy

• Early detection of molecular recurrence

• Monitoring treatment response and disease management

• Supporting clinical decision-making

When Is Signatera™ Used?

How Is Signatera™ Used Across Different Cancer Types?

• Colorectal Cancer

Following surgery and adjuvant treatment, serial ctDNA analysis with Signatera™ can be used to monitor minimal residual disease (MRD) and recurrence risk. This approach may help support adjuvant treatment decisions, follow-up planning, and the early detection of molecular recurrence.

• Breast Cancer

Serial ctDNA measurements during neoadjuvant treatment and after treatment can be used to monitor treatment response and molecular disease status. This may support the assessment of treatment response and recurrence risk.

• Non-Small Cell Lung Cancer (NSCLC)

Serial ctDNA monitoring with Signatera™ can be performed following surgery and systemic treatment. This may help with disease surveillance and the detection of molecular recurrence before clinical or radiological findings become apparent.

• Muscle-Invasive Bladder Cancer (MIBC)

MRD assessment with Signatera™ can be performed following radical cystectomy. This assessment may support the evaluation of recurrence risk and adjuvant treatment options. Signatera CDx has received FDA approval as a companion diagnostic for this use.

• Ovarian, Fallopian Tube, and Primary Peritoneal Cancers

Serial ctDNA measurements following treatment can be used to monitor molecular disease status and potential recurrence. This approach may support the early monitoring of recurrence and ongoing disease surveillance.

• Solid Tumors Treated with Immunotherapy

Serial ctDNA measurements during treatment can be used to monitor changes in tumor-derived DNA. This may support the assessment of molecular response to treatment and disease dynamics.

In addition to these cancer types, Signatera™ is used in gastrointestinal, genitourinary, head and neck cancers, lymphoma, sarcoma, and melanoma.

Why Signatera™?

• Assessment of treatment response in the neoadjuvant setting
• Identification of patients who may benefit from adjuvant therapy
• Early detection of molecular recurrence
• Monitoring of treatment response and disease management
• Support for optimized clinical decision-making

How Is Signatera™ Performed?

Setup: In the initial stage, the patient’s tumor tissue is analyzed to identify tumor-specific genetic alterations and establish a personalized tumor profile.

Follow-up: During follow-up, blood samples are collected at regular intervals to detect circulating tumor DNA. Serial measurements help monitor the patient’s response to treatment and the potential risk of molecular recurrence.

Our Test Options

*For patients with colorectal cancer (CRC), Latitude can be performed using a plasma sample only, without the need for tumor tissue.