Signatera™ Frequently Asked Questions
- RESULTS & REPORTS
- ORDERING & LOGISTICS
- 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 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
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: email@example.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: firstname.lastname@example.org