WHAT DO THE RESULTS MEAN?

A Signatera positive result indicates the presence of circulating tumor DNA (ctDNA) in your patient’s blood and by extension, the presence of tumor in the patient’s body. Positive results are highly correlated with inferior prognosis (e.g. reduced disease-free survival). The numerical value is associated with overall tumor burden for each patient, but only on a relative basis compared to previous Signatera results. In other words, the significance is in the trend; is the amount of ctDNA detected increasing, decreasing, stable from one time point to another. We have not proven that a certain quantity of ctDNA detected equates to a certain outcome, prognosis, tumor-burden or disease state; this likely varies from person to person. However, increases in MTM/mL for a given patient are associated with an increase in tumor burden for that patient and visa versa. A negative result indicates that ctDNA was not detected in your patient’s blood at a given timepoint. This does not mean that the patient is in remission (absence of cancer that has been treated), rather it could mean that the tumor burden that remains is at such low levels that it is not detected in the blood. For this reason, Signatera is best utilized when ordered repetitively, so that ctDNA detection and/or ctDNA levels can be assessed in a longitudinal manner. The longer the patient remains ctDNA negative, the more likely that individual will not relapse.

WHAT IS NEEDED TO START SIGNATERA?

Talk to your oncologists about ordering Signatera. Your oncologists will need to complete a requisition form requesting that Signatera be performed. After that, once we have received your initial blood samples our team will work with you pathologist to obtain tissue samples. If tissue is not available, Signatera cannot be performed.

HOW LONG DOES IT TAKE TO GET MY RESULTS?

The first time the Signatera test is ordered, it will take two weeks for tumor-tissue sequencing results to become available from the date the tumor tissue is received. Then, it will take another one week for your personalized test design and for your physician to receive the first Signatera test result. After the test has been designed, your Signatera test results will become available to your physician one to two weeks after your blood sample is received by the Natera laboratory.

HOW MUCH WILL IT COST PATIENTS?

If a patient is uninsured or concerned about their ability to pay for testing, they can complete an online application or contact one of our Patient Coordinators at signaterapc@natera.com

HOW DOES SIGNATERA BILLING WORK FOR RECURRING ORDERS VERSUS A SINGLE TEST ORDER?

Testing which occurs within the first 6 months after surgery is considered adjuvant testing. This is offered as a bundled service or recurring testing to include the initial whole exome sequencing (WES) + up to 4 tests.

HOW DOES SIGNATERA BILLING WORK IN THE SURVEILLANCE SETTING?

When a patient is greater than 6-months out in their postoperative treatment journey, they are in the surveillance setting. These patients have a history of cancer but no evidence of disease or disease recurrence. Signatera ordered in the surveillance setting is recommended at the same cadence as CEA, as directed by the treating physician. If a patient is ctDNA positive they cannot qualify as a surveillance patient as this is considered ‘active’ cancer.

ARE OTHER STAGES OR OTHER TYPES OF CANCER COVERED BY MEDICARE?

Medicare patients are fully covered under the following scenarios: Stage II/III colorectal cancer for Signatra testing With solid tumors on immuno-therapy for Signatera testing With stages III and IV solid tumors for Altera testing If Signatera is still requested for other cancer types which fall outside of the Medicare stated coverage, an ABN will be required.

CAN A PATIENT CANCEL AN ORDER?

Patients can cancel testing anytime up until the sample is received in the lab.

WHAT HAPPENS IF COVERAGE IS DENIED? HOW DOES THE APPEAL PROCESS WORK?

Natera Patient Coordinators will work with the patient’s insurance provider to file appeals and pursue coverage on the patient’s behalf.

DOES NATERA REACH OUT TO PATIENTS TO EXPLAIN THEIR POTENTIAL OUT OF POCKET PRIOR TO PROCESSING THE INITIAL SAMPLE?

A Patient Coordinator will reach out and contact the patient regarding coverage and potential out of pockets costs. They can also answer any questions that your patient may have about their Natera genetic testing bill.

Covered by Medicare for Select Indications

Signatera^™

Q: WHAT IS SIGNATERA AND WHAT DOES IT TEST FOR?

Signatera is a personalized molecular test for the detection of circulating tumor DNA (ctDNA) in the blood of patients previously diagnosed with cancer. This testing can be used to detect minimal, or molecular, residual disease (MRD) following surgery, to monitor response to cancer treatment, or detect cancer recurrence following a period of remission.

Q: HOW IS SIGNATERA DIFFERENT FROM CURRENT BIOMARKER TESTS?

Signatera is not a traditional oncology test. It does not focus on well-characterized mutations, oncogenes or hotspots like most tests. Instead, Signatera utilizes a WES-based, tumor-informed approach to create 16 bespoke assays that target specific, and generally unique, mutations found in your patient’s tumor, but absent in their germline DNA.

Q: HOW ACCURATE IS SIGNATERA?

Signatera is an extremely sensitive and specific test, due to the fact that it is customized specifically from your patient’s tumor. The specificity is >99.5%, and we are able to control for false positives that would result from the detection of natural background variants that occur in the patient’s DNA. The sensitivity is also remarkable as Signatera can detect a single ctDNA molecule from 10mL of plasma. In fact, our clinical studies have shown that over 50% of the time, Signatera will first detect the presence of ctDNA at a variant allele frequency (VAF) between 0.01-0.1%, far superior to our competitors who have a lower limit of detection equivalent to VAF between 0.1-1%.

Q: WHAT TYPE OF SAMPLES ARE NEEDED?

For initial testing we require one FFPE block with >25mm^2 of surface area (tissue block) and one H&E slide (preferred) OR 6-10 (10 microns) or 12-20 (5 microns) slides and one H&E slide (10 micron thickness). We also require two 10mL streck tubes and one 6mL EDTA tube. For subsequent testing, we require two 10mL Streck tubes only.

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

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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?

Signatera™ is covered by Medicare for monitoring disease progression, disease recurrence, or relapse for patients with:

Stage II-IV and oligometastatic colorectal cancer (CRC) in the adjuvant and recurrence monitoring settings
Muscle invasive bladder cancer (MIBC) in the adjuvant and recurrence monitoring settings
Stage II-IV breast cancer in the neoadjuvant setting, regardless of subtype
Stage IIb and higher breast cancer in the adjuvant and recurrence monitoring settings
Stage II-IV ovarian, fallopian tube, or primary peritoneal cancer in the adjuvant and recurrence monitoring settings
For monitoring of response to immune-checkpoint inhibitor (ICI) therapy for patients with any solid tumor

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

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