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Detect residual disease before it spreads

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

Detect residual disease before it spreads

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

Detect residual disease before it spreads

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

Detect residual disease before it spreads

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

How can Signatera be applied in clinical research and drug development?

In the clinical research setting, Signatera ctDNA analysis could be used as a tool for predicting the likelihood of relapse, monitoring response to neoadjuvant treatment, detecting minimal residual disease, monitoring for recurrence after adjuvant treatment, and monitoring for treatment efficacy and resistance.1-5

Well-designed and successful clinical trials could facilitate earlier “go/no go” decision-making, which may ultimately enhance the R&D pipeline productivity and impact label expansion of approved oncology drugs to the adjuvant setting.

Signatera ctDNA assay can be used to optimize aspects of clinical trial design that could increase the probability of trial success or accelerate trial completion, such as:

  • Patient stratification
  • Timing of treatment initiation
  • Duration of effective treatment
  • Improved accuracy of treatment-response measurement

 

Sample requirements

Signatera can accept other inputs, but for optimal performance, please follow these recommendations:

Primary tissue*

    One of the following:

  • Tissue block and 1 H&E slide (preferred)
  • 10, 5-micron slides with >5 mm2 tumor at >20% tumor content
  • 4-6 cores from core needle biopsies and 1 H&E slide

Blood

    One of the following:

  • Two tubes of whole blood collected in Streck® tubes or 10 mL of double-spun plasma
  • EDTA tubes are acceptable under certain conditions. Please contact us for further information
  • Minimum of 2 mL of plasma required

*Optional if the whole exome sequencing data are already available

Contact us with questions.

Sponsored research projects with leading institutions

Aarhus University

Cancer Research UK

Columbia University

Fox Chase Cancer Center

Imperial College of London

Institut Jules Bordet

Stanford University

UC San Francisco

University of Leicester

Vanderbilt University

Ongoing Studies

Collaborators Tumor type Study goal Patients studied
Institut Jules Bordet

Correlate results of ctDNA with clinical outcomes, including pathological response and event- free survival Non-metastatic, post-neoadjuvant therapy and post-surgery
Fox Chase Cancer Center

Determine relationship between kidney cancer genetic profiles and prognosis with ctDNA Patients with kidney cancer who recurred or did not recur after ≥3 years
Neon Therapeutics

Use of ctDNA to assess treatment response to the NEO-PV-01 personal cancer vaccine in combination with pembrolizumab and a chemotherapy regimen of pemetrexed and carboplatin in the NT-002 trial Untreated patients with advanced or metastatic non-squamous non-small cell lung cancer
Princess Margaret Cancer Centre

Assess patient response to immunotherapy in the metastatic setting by detecting ctDNA in the blood Patients with advanced cancers (including head and neck, triple-negative breast, melanoma, and ovarian) treated with single-agent pembrolizumab as part of the INSPIRE trial

Ongoing Studies

Collaborators Tumor type Study goal Patients studied
Institut Jules Bordet

Correlate results of ctDNA with clinical outcomes, including pathological response and event- free survival Non-metastatic, post-neoadjuvant therapy and post-surgery
Fox Chase Cancer Center

Determine relationship between kidney cancer genetic profiles and prognosis with ctDNA Patients with kidney cancer who recurred or did not recur after ≥3 years
Neon Therapeutics

Use of ctDNA to assess treatment response to the NEO-PV-01 personal cancer vaccine in combination with pembrolizumab and a chemotherapy regimen of pemetrexed and carboplatin in the NT-002 trial Untreated patients with advanced or metastatic non-squamous non-small cell lung cancer
Princess Margaret Cancer Centre

Assess patient response to immunotherapy in the metastatic setting by detecting ctDNA in the blood Patients with advanced cancers (including head and neck, triple-negative breast, melanoma, and ovarian) treated with single-agent pembrolizumab as part of the INSPIRE trial

Ongoing Studies

Collaborators Tumor type Study goal Patients studied
Institut Jules Bordet

Correlate results of ctDNA with clinical outcomes, including pathological response and event- free survival Non-metastatic, post-neoadjuvant therapy and post-surgery
Fox Chase Cancer Center

Determine relationship between kidney cancer genetic profiles and prognosis with ctDNA Patients with kidney cancer who recurred or did not recur after ≥3 years
Neon Therapeutics

Use of ctDNA to assess treatment response to the NEO-PV-01 personal cancer vaccine in combination with pembrolizumab and a chemotherapy regimen of pemetrexed and carboplatin in the NT-002 trial Untreated patients with advanced or metastatic non-squamous non-small cell lung cancer
Princess Margaret Cancer Centre

Assess patient response to immunotherapy in the metastatic setting by detecting ctDNA in the blood Patients with advanced cancers (including head and neck, triple-negative breast, melanoma, and ovarian) treated with single-agent pembrolizumab as part of the INSPIRE trial

Ongoing Studies

Collaborators Tumor type Study goal Patients studied
Institut Jules Bordet

Correlate results of ctDNA with clinical outcomes, including pathological response and event- free survival Non-metastatic, post-neoadjuvant therapy and post-surgery
Fox Chase Cancer Center

Determine relationship between kidney cancer genetic profiles and prognosis with ctDNA Patients with kidney cancer who recurred or did not recur after ≥3 years
Neon Therapeutics

Use of ctDNA to assess treatment response to the NEO-PV-01 personal cancer vaccine in combination with pembrolizumab and a chemotherapy regimen of pemetrexed and carboplatin in the NT-002 trial Untreated patients with advanced or metastatic non-squamous non-small cell lung cancer
Princess Margaret Cancer Centre

Assess patient response to immunotherapy in the metastatic setting by detecting ctDNA in the blood Patients with advanced cancers (including head and neck, triple-negative breast, melanoma, and ovarian) treated with single-agent pembrolizumab as part of the INSPIRE trial

BESPOKE Studies

In 2019 Natera plans to sponsor prospective, multicenter BESPOKE Studies, which will examine the clinical utility of the Signatera™ ctDNA test for monitoring recurrence and guiding treatment decisions in patients with solid tumors.

Contact us to learn more about collaborating with Natera in the BESPOKE Studies.

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

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References

  1. Abbosh C, Birkbak NJ, Wilson GA, et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017;545(7655):446-451.

  2. Reinert T, Henriksen TV, Rasmussen MH, et al. Serial Circulating Tumor DNA Analysis for Detection of Residual Disease, Assessment of Adjuvant Therapy Efficacy and for Early Recurrence Detection in Colorectal Cancer. Poster presented at: European Society for Medical Oncology Annual Congress; October 21, 2018; Munich, Germany. Abstract 456PD.

  3. Birkenkamp-Demtröder K, Christensen E, Sethi H, et al. Sequencing of Plasma cfDNA from Patients with Locally Advanced Bladder Cancer for Surveillance and Therapeutic Efficacy Monitoring. Poster presented at: European Society for Medical Oncology Annual Congress; October 20, 2018; Munich, Germany. Abstract 86P.

  4. Coombes RC, Armstrong A, Ahmed S. Early detection of residual breast cancer through a robust, scalable and personalized analysis of circulating tumor DNA (ctDNA) antedates overt metastatic recurrence. Poster presented at: San Antonio Breast Cancer Symposium; December 7, 2018. San Antonio, TX. Abstract 1266.

  5. Magbanua MJM, Brown-Swigart L, Hirst GL. Personalized serial circulating tumor DNA (ctDNA) analysis in high-risk early stage breast cancer patients to monitor and predict response to neoadjuvant therapy and outcome in the I-SPY 2 trial. Poster presented at: San Antonio Breast Cancer Symposium; December 5, 2018. San Antonio, TX. Abstract 1259.

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