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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.

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.

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 2-3 weeks after receipt of tumor and blood samples. Subsequent blood draws have a turnaround time of 5-7 days.

IS SIGNATERA COVERED BY MEDICARE ?

Medicare patients are fully covered for Stage II and III colorectal cancer, Stage IV oligometastatic colorectal cancer, and pan-cancer immunotherapy monitoring.

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

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.