Oncology Patients Information | Signatera Patient Information

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Oncology Patients Information

Knowing early can make a difference

If you have had surgery to remove a tumor, you and your doctor may want to know as early as possible if any cancer cells are still in your body. This important oncology patient information can help determine:

  • if additional treatment should be considered
  • if you are responding to your current treatment
  • if there are signs that the cancer has returned or progressed

Though imaging tools used by your doctor (such as MRI or CT scan) in oncology centers are essential to help determine your cancer status, they are limited in their ability to detect very small traces of cancer cells in your blood— called molecular residual disease or MRD. If left untreated, residual cancer cells can multiply, resulting in cancer recurrence.1


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


Personalized and Tumor-informed Monitoring

The Signatera circulating tumor DNA analysis in patients with cancer accurately detects small traces of circulating tumor in your blood, providing your doctor with an important new guidance tool to help support more informed decisions.

  • Personalized for oncology patients—custom-built to generate results based on your unique set of tumor mutations
  • Tumor-informed—selects and tracks tumor mutations (or changes) that are specific to your individual tumor, enabling highly accurate monitoring of the presence or absence of disease over time

How does Signatera work?


An analysis of both blood and tissue 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-built and personalized for you

Signatera selects 16 tumor DNA mutations that occurred early in your cancer’s origination. These mutations are called “clonal mutations,” are specific only to you, and would be present in all future cancer cells.

Signatera detects the presence or absence of circulating tumor DNA (ctDNA)

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 over the course of the cancer continuum.


Understanding your Signatera test results

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.

Negative Result

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.

IMPORTANT: Negative results may change over time. A negative Signatera result doesn’t guarantee that tumor DNA is not in your blood, or that it will never be detected in the future. This is why ongoing monitoring with the Signatera test in oncology treatment centers over the course of your cancer care, as directed by your doctor, is recommended—for early detection of residual disease.

 

 

Positive Result

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.


Questions about Signatera? Contact us.


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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.