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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

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 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 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

 

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 actionable 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

Plasma-based exome analysis (coming soon)

 

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

 

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.

Options

  • Information on prevalence of ctDNA positive after surgery
  • Optimization of the MRD time-point and number of time-points for clinical trial enrollment
  • Recommendation on optimal number and frequency of time-points for treatment response surveillance
  • Exome-wide analysis of tumor mutation burden (TMB) with germline control
  • Analysis of data for prevalence of clonal hematopoiesis of indeterminate potential (CHIP) mutations

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