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Detect residual disease before it spreads

Introducing the first ctDNA molecular monitoring tool – the sooner you know, the sooner you can act

Detect residual disease before it spreads

Introducing the first ctDNA molecular monitoring tool – the sooner you know, the sooner you can act

Detect residual disease before it spreads

Introducing the first ctDNA molecular monitoring tool – the sooner you know, the sooner you can act

Detect residual disease before it spreads

Introducing the first ctDNA molecular monitoring tool – the sooner you know, the sooner you can act

Knowing early is important.

Why is cancer monitoring important?

There are several monitoring tools that doctors use to detect the cancer remaining in the body of someone who as been treated for cancer. Knowing if there are traces of cancer present can help the doctor or oncologist decide:

  • how and whether the patient is responding to treatment
  • if further or different cancer treatment should be considered
  • whether there are signs that the cancer has returned or progressed

However, these imaging tools are limited in their ability to detect molecular residual disease (MRD)—very small traces of cancer in the blood. If left untreated, residual cancer cells are highly likely to multiply and cause a recurrence.1

 

Molecular residual disease (MRD) is the
presence of small traces of cancer in the
blood, such as circulating tumor DNA (ctDNA)
or microscopic pieces of tumor DNA.

Signatera is a new cancer-monitoring test that is personalized for each patient

Signatera is a custom-designed test that is generated based on each patient’s unique set of tumor mutations.

Knowing earlier if your cancer is likely to recur or has progressed after treatment can help you have a more informed discussion with your doctor on how to continue to treat or monitor your disease.

How does Signatera work?

  •     An analysis determines your unique tumor DNA mutations

    The DNA sequence from your tumor tissue is compared to normal cells from your blood to determine the unique set of mutations specific to your tumor tissue. This process happens only once.

  •     The test is custom-designed and personalized for you

    The next step of the Signatera process is to select 16 tumor DNA mutations that occurred early in your cancer’s origination. These mutations are called “clonal mutations” and would be present in all future cancer cells. The clonal mutation selection process happens only once.

  •     Signatera detects the presence or absence of tumor DNA

    Once your personalized Signatera test is created, it can be used to detect the presence or absence of tumor DNA from any future blood samples.

How does Signatera work?

  •     An analysis determines your unique tumor DNA mutations

    The DNA sequence from your tumor tissue is compared to normal cells from your blood to determine the unique set of mutations specific to your tumor tissue. This process happens only once.

  •     The test is custom-designed and personalized for you

    The next step of the Signatera process is to select 16 tumor DNA mutations that occurred early in your cancer’s origination. These mutations are called “clonal mutations” and would be present in all future cancer cells. The clonal mutation selection process happens only once.

  •     Signatera detects the presence or absence of tumor DNA

    Once your personalized Signatera test is created, it can be used to detect the presence or absence of tumor DNA from any future blood samples.

How does Signatera work?

  •     An analysis determines your unique tumor DNA mutations

    The DNA sequence from your tumor tissue is compared to normal cells from your blood to determine the unique set of mutations specific to your tumor tissue. This process happens only once.

  •     The test is custom-designed and personalized for you

    The next step of the Signatera process is to select 16 tumor DNA mutations that occurred early in your cancer’s origination. These mutations are called “clonal mutations” and would be present in all future cancer cells. The clonal mutation selection process happens only once.

  •     Signatera detects the presence or absence of tumor DNA

    Once your personalized Signatera test is created, it can be used to detect the presence or absence of tumor DNA from any future blood samples.

How does Signatera work?

  •     An analysis determines your unique tumor DNA mutations

    The DNA sequence from your tumor tissue is compared to normal cells from your blood to determine the unique set of mutations specific to your tumor tissue. This process happens only once.

  •     The test is custom-designed and personalized for you

    The next step of the Signatera process is to select 16 tumor DNA mutations that occurred early in your cancer’s origination. These mutations are called “clonal mutations” and would be present in all future cancer cells. The clonal mutation selection process happens only once.

  •     Signatera detects the presence or absence of tumor DNA

    Once your personalized Signatera test is created, it can be used to detect the presence or absence of tumor DNA from any future blood samples.

How long will it take to receive Signatera test 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 two weeks 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.

Understanding the Signatera test results

The test result 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. 

A positive Signatera test result indicates that tumor DNA has been detected in your blood. A positive result means there is higher risk for your cancer returning if you were diagnosed with early-stage cancer. Changes in ctDNA levels could also be used by our doctor to monitor your tumor's response to treatment.

A negative Signatera test result indicates that tumor DNA was not detected in your blood. A negative result means 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 the therapy was able to decrease the amount of cancer cells to levels undetectable to the Signatera test.

No test is perfect, and negative results may change over time. A negative Signatera result doesn’t guarantee that tumor DNA was not in your blood, nor does it guarantee that it will never be detected in the future. This is why periodic use of the Signatera test over the course of your cancer care as directed by your doctor is recommended: to detect changes in the presence or absence of tumor DNA.

Limitations of the test: While the Signatera test is highly sensitive and specific, no screening test is 100% accurate in predicting cancer progression status. A negative Signatera test result does not guarantee that your cancer is cured or that you will remain cancer-free forever. A positive Signatera test result does not indicate that every patient will have a recurrence of cancer. Signatera is not designed to detect ctDNA in patients with more than one primary cancer, provde treatment selection guidance, or test for hereditary cancer syndromes.

How accurate is the Signatera molecular monitoring test?


Signatera has been studied in multiple clinical studies across many solid cancer tumor types, including bladder, breast, colon, and lung.2-5

Studies show that, if there is a single molecule of tumor DNA in a tube with 10 mL of blood, the Signatera test will find it >90% of the time.6 If there are two molecules of tumor DNA in a tube of blood, Signatera will find it >99% of the time.6 This level of sensitivity, or the test’s ability to correctly identify the presence of MRD, is what makes Signatera unique. Signatera can detect small amounts of tumor DNA before cancer recurrence can be seen using traditional imaging tools such as CT scans or MRI.2-5

Performance of Signatera in clinical studies of non-metastatic patients across several common cancer types

 

Cancer type Risk of cancer recurrence after a postive result* Average time MRD was detected before clinical recurrence Maximum time MRD was detected before clinical recurrence
Colorectal cancer3 93% 8.7 months 16.5 months
Breast cancer5 > 99% 9.5 months 2 years
              HR+/HER2- > 99% 10.9 months 2 years
              HER2+ > 99% 5.5 months 10.4 months
              TNBC > 99% 8.5 months 1 year 7 months
Non-small cell lung cancer2 > 99% 4 months 11.5 months
Muscle invasive bladder cancer4 93% 2.8 months 8.2 months

 

*Without receiving further treatment. ✝Versus imaging tools, without further treatment.

Performance of Signatera in clinical studies of non-metastatic patients across several common cancer types

 

Cancer type Risk of cancer recurrence after a postive result* Average time MRD was detected before clinical recurrence Maximum time MRD was detected before clinical recurrence
Colorectal cancer3 93% 8.7 months 16.5 months
Breast cancer5 > 99% 9.5 months 2 years
              HR+/HER2- > 99% 10.9 months 2 years
              HER2+ > 99% 5.5 months 10.4 months
              TNBC > 99% 8.5 months 1 year 7 months
Non-small cell lung cancer2 > 99% 4 months 11.5 months
Muscle invasive bladder cancer4 93% 2.8 months 8.2 months

 

*Without receiving further treatment. ✝Versus imaging tools, without further treatment.

Performance of Signatera in clinical studies of non-metastatic patients across several common cancer types

 

Cancer type Risk of cancer recurrence after a postive result* Average time MRD was detected before clinical recurrence Maximum time MRD was detected before clinical recurrence
Colorectal cancer3 93% 8.7 months 16.5 months
Breast cancer5 > 99% 9.5 months 2 years
              HR+/HER2- > 99% 10.9 months 2 years
              HER2+ > 99% 5.5 months 10.4 months
              TNBC > 99% 8.5 months 1 year 7 months
Non-small cell lung cancer2 > 99% 4 months 11.5 months
Muscle invasive bladder cancer4 93% 2.8 months 8.2 months

 

*Without receiving further treatment. ✝Versus imaging tools, without further treatment.

Performance of Signatera in clinical studies of non-metastatic patients across several common cancer types

 

Cancer type Risk of cancer recurrence after a postive result* Average time MRD was detected before clinical recurrence Maximum time MRD was detected before clinical recurrence
Colorectal cancer3 93% 8.7 months 16.5 months
Breast cancer5 > 99% 9.5 months 2 years
              HR+/HER2- > 99% 10.9 months 2 years
              HER2+ > 99% 5.5 months 10.4 months
              TNBC > 99% 8.5 months 1 year 7 months
Non-small cell lung cancer2 > 99% 4 months 11.5 months
Muscle invasive bladder cancer4 93% 2.8 months 8.2 months

 

*Without receiving further treatment. ✝Versus imaging tools, without further treatment.

When should the Signatera test be considered?

  • At initial cancer diagnosis, to establish a baseline before surgery or treatment
  • After surgery, before starting chemotherapy
  • During treatment, to evaluate treatment response
  • After treatment, to monitor for molecular residual disease or tumor response to treatment

This test can only be ordered by a licensed oncologist. Talk to your doctor to see if you may be a candidate for the Signatera test.

Signatera Billing and Customer Care: 650.489.9050
Hours of operation: Monday - Friday 7am-7pm CST and Saturday 8am-5pm CST
Email: support@natera.com 

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References

  1. Corcoran RB, Chabner BA. Application of cell-free DNA analysis to cancer treatment. N Engl J Med. 2018;379(18):1754-1765.
  2. Abbosh C, Birkbak NJ, Wilson GA, et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017;545(7655):446-451.
  3. Reinert T, Henriksen TV, Christensen E, et al. Analysis of plasma cell-free DNA by ultradeep sequencing in patients with stages I to III colorectal cancer [published online ahead of print May 9, 2019]. JAMA Oncol. 2019. doi:10.1001/jamaoncol.2019.0528.
  4. Christensen E, Birkenkamp-Demtröder K, Sethi H, et al. Early detection of metastatic relapse and monitoring of therapeutic efficacy by ultra-deep sequencing of plasma cell-free DNA in patients with urothelial bladder carcinoma [published online ahead of print May 6, 2019]. J Clin Oncol. 2019. doi:10.1200/JCO.18.02052.
  5. Coombes RC, Page K, Salari R, et al. Personalized detection of circulating tumor DNA antedates breast cancer metastatic recurrence [published online ahead of print April 16, 2019]. Clin Cancer Res. 2019. doi:10.1158/1078-0432.CCR-18-3663.
  6. Sethi H, Salari R, Navarro S, et al. Analytical validation of the Signatera™ RUO assay, a highly sensitive patient-specific multiplex PCR NGS-based noninvasive cancer recurrence detection and therapy monitoring assay. Poster presented at: American Association for Cancer Research (AACR) Annual Meeting; April 17, 2018; Chicago, IL. Abstract 4542.
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