Signatera Personal molecular test to monitor minimal residual disease (MRD) and early detection of cancer recurrence

Signatera is a personalized molecular genetic test designed to detect circulating tumor DNA (ctDNA) in the blood of patients who have previously been diagnosed with cancer.

This test can be used to detect signs of minimal or molecular residual disease after surgery, monitor response to cancer treatment, or detect cancer recurrence following a period of remission.

What questions can the Signatera test answer?

• Is there any cancer remaining in the body after surgery?
• Is the treatment effective?
• Is there a risk of cancer recurrence?

Why is this important?

• Because the Signatera™ panel is developed individually based on each patient’s tumor tissue, the test is highly sensitive and can detect microscopic fragments of tumor DNA present in the blood
• Signatera™ enables longitudinal monitoring of ctDNA levels in real time, meaning that the test can identify the risk of recurrence earlier than standard imaging methods
• Understanding changes in ctDNA levels at the earliest stages supports more informed clinical treatment decisions

How Signatera™ works: A personalized and informed approach to monitoring.

• A one-time analysis of blood and tumor tissue identifies your unique set of tumor mutations.
• The test is individually designed and personalized specifically for you using your own tumor tissue.
• The Signatera™ test can detect small fragments (molecules) of circulating tumor DNA each time it is ordered as part of your follow-up blood testing. Patients in whom circulating tumor DNA is detected (a positive Signatera result) are more likely to experience recurrence.

Benefits:

Early detection of recurrence:

Signatera™ testing protocols can detect circulating tumor DNA (ctDNA) significantly earlier than standard clinical assessments, with high sensitivity. In validation studies, molecular recurrence detected by Signatera™ preceded clinical recurrence by:

• an average of 8.7 months in colorectal cancer
• an average of 9.5 months in breast cancer
• an average of 4 months in lung cancer
• an average of 2.8 months in muscle-invasive bladder cancer
• Is your treatment effective? (for example, chemotherapy, radiation therapy, or immune checkpoint inhibitors)

In addition, clinical studies conducted by the company showed that patients with a positive Signatera™ result after surgery had poorer recurrence-free survival compared with patients who had a negative test result. This allows the test to be used for postoperative risk stratification and to support early clinical decision-making regarding the need for adjuvant chemotherapy and the timing of treatment escalation or dose adjustment. The high performance of the Signatera™ test has been demonstrated across solid tumors.

Non-invasive testing:

Using a simple blood test to monitor ctDNA reduces the need for more invasive procedures, such as biopsies, which are often difficult or impractical for regular monitoring.

Comprehensive information:

Circulating tumor DNA analysis can provide a broad picture of the disease by identifying mutations and genetic alterations that may be driving the cancer, helping to guide subsequent therapy selection.

Unique technology

Not all circulating tumor DNA tests are equally accurate and effective, making it important to choose the most reliable methods. Signatera™ is one of the most comprehensive tests available for detecting circulating tumor DNA in the blood. Read our peer-reviewed publications here.

Absolute test limitations:

• Testing cannot be performed in patients who have undergone bone marrow transplantation or received a blood transfusion within the past three months.
• Testing cannot be performed when a cancerous tumor is detected in an organ that was previously transplanted into the patient.
• Testing cannot be performed in patients who have undergone stem cell transplantation (SCT).
• Signatera has limited sensitivity for certain types of cancer, including gastrointestinal stromal tumors, renal cell carcinoma, primary brain tumors, and lymphoma, due to limited ctDNA shedding (each case is assessed individually, and consultation with the laboratory may be possible).
• Each Signatera test is designed for only one tumor type. If you have a history of two different cancers at the same time, you are advised to undergo two separate Signatera tests or to test the more aggressive of the identified cancers.