Signatera Research Pipeline | Natera

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 enrichment (e.g., ctDNA prevalence after surgery)
  • Identification of new patient population (e.g., MRD relapsers)
  • Treatment escalation / deescalation strategies 
  • Early response measurement
  • Duration of effective treatment 
  • Surrogate endpoint

 


 

 


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

BESPOKE Studies

Natera sponsors prospective, multicenter BESPOKE Studies, which examine the clinical utility of the Signatera™ ctDNA test for monitoring recurrence and guiding treatment decisions in patients with solid tumors. Want to collaborate with Natera in our current Colorectal Cancer BESPOKE Study?

Learn More: BESPOKE Study


Research and genomic sequencing offerings

For scientists looking to answer research questions using insights from Signatera’s technology and datasets, our services can help you incorporate ctDNA status in clinical trial design to enrich for patients with MRD, as a surrogate for early efficacy readout, and to treat on first sign of molecular relapse.


1

Signatera residual disease test

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.

Natera can provide support for clinical trial design using Signatera. Signatera ctDNA status can be incorporated in clinical trial design to enrich for patients with MRD, as a surrogate for early efficacy readout, and to treat on first sign of molecular relapse.

  • Signatera for clinical use: personalized and tumor-informed 16-plex PCR (now available)
  • Signatera for research use: Flexibility to design customized assays for your targets of interest
  • Ability to reanalyze samples from the initial DNA library (eg, track neoantigens, actionable mutations, and tumor evolution)
  • Ability to design multiplex PCR from targeted tumor panels, without whole exome sequencing (WES), or without matched normal
2

Plasma-based exome analysis

  • Supports Signatera design when tumor tissue is not available
  • Plasma serial profiling of tumor burden and evolution
3

Clinical insights and trial design

Leverage Natera’s clinical, statistical, and bioinformatics expertise to optimize your trial design and interpret trial results.

Natera has developed a database of tissue, germline, and ctDNA results from thousands of clinical samples, with a range of tumor types and stages of cancer. As part of the clinical trial design service, Natera will analyze historical data from our proprietary database and to provide insight and recommendations for how to optimize your clinical trial, along with personalized service from Natera’s medical, R&D, and bioinformatics team.

4

Tissue-based exome analysis

Test Average DOR for exome analysis Use Case Report
Basic
  • Tissue:180x
  • Matched normal 50x
  • TAT: 2 weeks
  • Supports Signatera design
  • IDeal for local and regional stage patients where report of clinically actional genes or interpretation of tissue analysis is not required

Raw sequencing data (BAM or FASTQ)

Clinical Boosted
  • Tissue: 400x
  • Matched normal: 180x
  • Boosted coverage: ~800x of clinically relevant genes
  • WTS: 100M reads (50 million clusters)
  • TAT: 2 to 3 weeks
Ideal for wild-type patients, or for research and discovery purposes Full report of WES/WTS and interpretation provided

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

*Optional if the whole exome sequencing data are already available

Contact us

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.
  • Minium of 2 mL of plasma required