Signatera | Applications | Natera

Research Applications

Research Applications

Research Applications

Research Applications

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

In the clinical research setting, Signatera (RUO) 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.1-3

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 (RUO) 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 (RUO) 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

CLEAR Study

In early 2019, Natera plans to sponsor a prospective, multicenter CLEAR (ctDNA Longitudinal Collection for Early Assessment of Residual Disease) Study. The CLEAR study will examine the clinical utility of the Signatera™ ctDNA test for guiding treatment and monitoring decisions in patients with cancer.

Contact us to learn more about collaborating with Natera in the CLEAR Study.

Signatera - Contact Us

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. Personalized circulating tumor DNA analysis to monitor colorectal cancer. Poster presented at: American Association for Cancer Research Annual Meeting; April 17, 2018; Chicago, IL. Abstract 1590.

  3. Birkenkamp-Demtröder K, Christensen E, Sharma S, et al. Sequencing of plasma cfDNA from patients with locally advanced bladder cancer for surveillance and therapeutic efficacy monitoring. Poster presented at: American Association for Cancer Research Annual Meeting; April 17, 2018; Chicago, IL. Abstract 3653.
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