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Signatera

Transforming the management of cancer with personalized testing

Signatera™ is a highly sensitive and personalized molecular residual disease assay (MRD) using circulating tumor DNA (ctDNA), custom designed for each patient to help identify relapse earlier than standard of care tools.

Is Signatera™ right for you? Learn more here

Signatera™ Frequently Asked Questions

  • OVERVIEW
  • RESULTS & REPORTS
  • ORDERING & LOGISTICS
  • BILLING
  • CUSTOMER EXPERIENCE
What is Signatera™ and what does it test for?

Signatera™ is a personalized, tumor-informed assay optimized to detect circulating tumor DNA (ctDNA) for molecular residual disease (MRD) assessment, treatment response monitoring, and early recurrence monitoring.

How is Signatera™ different from current biomarker tests?

Unlike other ctDNA assays, Signatera™ is designed to accurately detect MRD (i.e., not designed for early cancer screening nor for identifying actionable mutations for therapy selection). Instead, Signatera™ is customized for each patient’s unique tumor signature to optimize sensitivity and specificity for accurate MRD assessment.

What can MRD testing tell me about my cancer?

A negative result indicates that tumor DNA was not detected in your blood and that you are more likely to remain cancer-free if you were diagnosed with early-stage cancer. If you have metastatic cancer, a negative result may mean that your treatment was able to decrease the amount of cancer cells to undetectable levels, meaning the treatment has been effective. A positive result indicates that tumor DNA has been detected in your blood and means there is higher risk for your cancer returning if you were diagnosed with early-stage cancer. Your doctor may continue to monitor your ctDNA levels to assess your tumor’s response to treatment.

How will MRD results impact my treatment plan?

Your test results will either be positive or negative for the presence of tumor DNA in your blood. Your doctor will receive the test report and will be able to discuss your results and answer questions. These results provide additional insights and may help guide your treatment plan. It is important to know that ctDNA results may change over time. A negative MRD test result doesn’t guarantee that cancer will never be detected in the future. This is why ongoing monitoring with the Signatera™ test, as directed by your doctor, is recommended—for early detection of residual disease.

How often should I get a Signatera™ test?

How often Signatera™ is ordered will be determined by your care team but generally it is ordered every 3 months through a simple blood draw. Natera’s also offers convenient blood draws through our Mobile Phlebotomy service. The Patient Coordinator team will call to provide a variety of blood draw options and schedule appointments that work for you.

How accurate is Signatera™?

By only tracking tumor-specific variants, sensitivity is maximized with a low limit of detection (LOD) of 0.01% variant allele frequency (VAF). Also, Signatera™ filters out clonal hematopoiesis of indeterminate potential (CHIP) mutations to greatly reduce false-positive results.

What information does the test report provide?

Signatera™ reports the presence or absence of circulating tumor DNA (ctDNA) and ctDNA quantity in terms of mean tumor molecules per mL (MTM/mL) to allow for assessment of tumor burden over time.

What does a positive Signatera™ result mean?

A positive test result indicates the presence of molecular residual disease (MRD). Serial sampling can be used to track whether disease burden is increasing or decreasing in response to treatment.

What does a negative Signatera™ result mean?

A negative result indicates that molecular residual disease (MRD) was not detected. Serial sampling can be used to track whether disease burden remains undetectable or increases to catch relapse early.

How do I get Signatera™ testing?

Ask your physician if Signatera™ is right for you.

What type of samples are needed for Signatera™?

For initial testing, tumor tissue will need to be provided as a formalin-fixed paraffin-embedded (FFPE) block or on slides. The first blood draw will require one 6 ml EDTA tube and two 10 mL Streck tubes. All subsequent draws will only require two 10 mL Streck tubes.

What is the turnaround time for my Signatera™ results?

Initial test design takes 3-4 weeks after receipt of tumor and blood samples. Subsequent blood draws have a turnaround time of 7-10 days.

Is Signatera covered™ by Medicare?

Medicare patients are fully covered for:

  • Colorectal cancer
  • Muscle invasive bladder cancer
  • Pan-cancer immunotherapy monitoring
  • Breast cancer

For more information, please visit the Patient Access Guide.

Who can I contact if I have questions about my Natera genetic testing bill?

For questions or financial assistance, please contact Natera’s Patient Coordinators via Phone: 1.650.489.9050 or Email: signateracc@natera.com

For additional questions regarding cost, Natera’s billing phone number is 1-844-384-2996. Support is available between 7 am – 7 pm Central Time, Monday-Friday, for questions about your Natera genetic and carrier testing bill.

Where can I get my blood drawn for Signatera™?

Blood can be drawn either by the clinic on-site or by Natera’s mobile phlebotomy service. For questions, please contact Customer Care via Phone: 1.650.489.9050 or Email: signateracc@natera.com

Is Signatera™ right for you?

We’re here to help you find out.


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