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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

Detect residual disease early.
Treat with confidence.

Highly accurate MRD testing uniquely personalized to each patient’s tumor mutation signature

  • Highly sensitive non-invasive assay to detect MRD earlier than other standard of care clinical tools.1‑4
  • Earlier cancer recurrence monitoring to help inform adjuvant treatment decisions.
  • Custom-built for each patient, using tumor tissue from surgical resection.
  • Highest level of monitoring accuracy when determining whether to augment or reduce therapy.

Signatera has significant predictive value for long-term patient outcomes

The only significant risk factor in stage II-III colorectal cancer5‑8

In multivariate statistical analysis, MRD status as measured by Signatera was the only significant predictor of long-term cancer patient outcomes, after adjusting for all known clinicopathological risk factors including disease stage and lymph node status.1

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Learn what was discovered at our satellite symposia at ESMO GI 2021

Natera presented an interim analysis from the CIRCULATE-Japan trial, the largest prospective, multi-center, MRD-guided trial for colorectal cancer (CRC) patients, demonstrating that Signatera can identify which colorectal cancer patients are likely to benefit from adjuvant chemotherapy (ACT) and conversely those who are unlikely to benefit from ACT, across all stages

When to use Signatera?

Adjuvant setting

  • Use Signatera after surgery to evaluate the need for adjuvant chemotherapy
  • Personalize and help inform when to reduce treatment

Surveillance setting

  • Assess for MRD more accurately than current risk-assessment methods
  • Use Signatera alongside CEA to detect recurrence earlier while it may still be resectable, or to reduce false positive CEA results

How Signatera Works: a personalized and tumor informed approach to MRD surveillance

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Personalized, tumor-informed assay

One-time, primary tissue sample and matched normal tissue is required for whole exome sequencing and personalized test design.

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Ultrasensitive ctDNA detection

Signatera is designed to detect ctDNA of somatic and truncal variants to optimize sensitivity. Tumor-informed method enables filtering of CHIP mutations to decrease false positive rates.

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Optimized for longitudinal monitoring

Once the patient’s personalized test has been designed, only a blood sample is needed each subsequent time Signatera is ordered for the adjuvant program or surveillance program.

Signatera high sensitivity and specificity
“Detecting relapse before it becomes clinically symptomatic requires a test with high sensitivity and specificity. Signatera enables us to confidently identify patients with molecular relapse when the disease burden is so low that it is undetectable with imaging.”
Lajos Pusztai, MD, DPhil

Lajos Pusztai, MD, DPhil

Professor of Medicine (Medical Oncology); Co-Leader, Genetics, Genomics and Epigenetics Research Program, Yale Cancer Center, Yale School of Medicine

Signatera can help guide care for your cancer patients

Risk level Actionable results: Stage II-III Colorectal Test Interpretation
ctDNA High Risk Consider directed imaging (PET/MRI) to locate the disease while potentially resectable >97% of patients will relapse
ctDNA Reduced Risk Continue monitoring with reassurance 12-14% patients may relapse. Patients who remain negative 2 years post treatment have risk reduced to 3%
Bespoke CRC

Do your patients qualify for the BESPOKE CRC trial?

Our prospective, multicenter study examines the clinical utility of the Signatera ctDNA test for monitoring recurrence and guiding treatment decisions in patients with solid tumors. Find out if your patients qualify for the BESPOKE clinical trial.

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How to order

To get started, send in your Signatera requisition form, sign in to the online portal or talk to your sales representative.

Workflow-Step 1_2x

Step 1

Send tumor block or slides to prepare the personalized tumor-informed assay

Workflow-Step 2_2x

Step 2

Complete information on tube labels

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Step 3

Place filled and labeled tubes into the absorbent sleeve and into the metallic envelope. Place the metallic envelope into the biohazard bag.

Natera accepts all commercial and public insurances (Medicare, Medicaid)

We are committed to make testing as affordable as possible

Medicare Coverage
Serial and single time point use of Signatera MRD in patients with stage II-IV colorectal cancer1 (Other indications are welcome however an ABN may be required*)

Patients being treated with immunotherapy, regardless of stage and tumor type
Commercial Insurance
We welcome all insurance plans

We will work with patients so that cost is not a barrier for testing

We offer an affordable cash pay rate for those patients who do not wish to use insurance

Is Signatera right for you?

We’re here to help you find out



References

1Corcoran RB, Chabner BA. N Engl J Med. 2018;379(18):1754-1765.

2Kramer J, Price ER, Jochelson MS, et al. Eur Radiol. 2017;27(11):4812-4818.

3Borcoman E, Nandikolla A, Long G, Goel S, Le Tourneau C. Am Soc Clin Oncol Educ Book. 2018;38:169-178.

4Perkins GL, Slater ED, Sanders GK, Prichard JG. Am Fam Physician. 2003;68(6):1075-1082.

5Reinert T, Henriksen TV, Christensen E, et al. JAMA Oncol. 2019. doi:10.1001/jamaoncol.2019.0528.

6Sinicrope FA, Foster NR, Thibodeau SN, et al. J Natl Cancer Inst. 2011;103(11):863–875.

7Aoyama, Oba K, Honda M, et al. Cancer Med. 2017;6(7):1573–1580.

8Yothers G, O’Connell MJ, Lopatin M, et al. J Clin Oncol. 2013;31(36):4512-4519.

9Kotaka et al. ASCO GI 2022.