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Why partner with Signatera for your clinical trial?

  • Clinically validated across multiple solid tumors, Signatera has shown to predict relapse in >98% of patients without further treatment1
  • Experienced team with Global reach: CE Mark, three FDA Breakthrough Device Designations, 8 Non-Significant Risk (NSR) determinations
  • >60 Natera IP assets covering ctDNA MRD and monitoring

Our partners choose Signatera because well-designed and successful clinical trials could facilitate earlier “go/no go” decision-making. A trial with Signatera can ultimately enhance the R&D pipeline productivity and impact label expansion of approved oncology drugs to new treatment settings.

What are the applications of Signatera in a Clinical Trial?

Use case signatera advantage
Surrogate Endpoint ctDNA status during and after treatment helps you to predict clinical outcomes
as early as 6 weeks into treatment
Patient Enrichment Select patients likely to respond to therapy due to residual disease presence
(i.e., ctDNA positive)
Platform Identify ‘winning / losing’ regimens faster by enriching and quickly
identifying active regimens
Treat on Molecular Relapse Potential to define new patient population by treating at early
identification of relapse vs conventional methods
Immuno-oncology Potential to improve patient outcomes by avoiding over-treatment,
treating to undetectable ctDNA (early stage), and timely switching of therapies
Secondary pools Track neoantigens, resistance mutations, sub-clonal mutations
and driver mutations.

Learn more about Pan-tumor Innovative Clinical Trial Design with Signatera

Growing List of Publicly Announced Studies

Genentech IMvigor011 trial Bladder cancer Phase 3 READ MORE
Aarhus University Bladder cancer RUO READ MORE
GSK ZEST trial Breast cancer Phase 3 READ MORE
Imperial College London Breast cancer RUO READ MORE
Institut Jules Bordet Breast cancer RUO READ MORE
Yale and Criterium/Academic Breast Cancer Consortium (ABRCC) network – DARE Breast cancer Phase 2 READ MORE
Massachusetts General Hospital – LEADER Breast cancer Phase 2 READ MORE
AMAL Therapeutics – KISIMA-01 trial CRC Phase 1b READ MORE
Arhaus University CRC RUO READ MORE
Natera – BESPOKE trial CRC Registry trial READ MORE
NCC Japan – CIRCULATE-IDEA trial CRC Registry trial READ MORE
Fox Chase Cancer Center Kidney cancer RUO READ MORE
Bristol-Myers – TRACERx trial Lung cancer Phase 2 READ MORE
Neon Therapeutics – NEO-PV-01 trial Lung cancer Preclinical READ MORE
Elicio Therapeutics – ELI-002 trial Pancreatic ductal
Phase 1/2 READ MORE

Join our 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?

Contact us

Is Signatera CLIA or Signatera RUO right for your clinical trial?

Parameter CLIA RUO
  • For registrational clinical trials
  • For patient-level clinical decisions
  • For retrospectively batched sample studies
  • Signal-finding studies, pilots
Turnaround time
  • 2-3 weeks for first sample
  • 5-7 days for subsequent
  • Longer turnaround times due to customization
Assay variants and design
  • Personalized and tumor-informed 2 to 16-plex PCR
  • Flexible in number of variants to track
  • Design customized assays for your targets of interest
  • Run secondary pools from the residual cfDNA library (eg, track neoantigens, actionable mutations, and tumor evolution)
  • Design multiplex PCR from targeted tumor panels, without WES
Number of assays per patient
  • One 16-plex PCR per patient
  • Can create up to 4 assays with multiple/synchronous tumors
  • Can create >16-plex assay depending on tumor genome/exome profile
Depth of read
  • WES >180X average coverage (>70% at 100X) for tumor tissue and >50X average coverage (>70% at 30X) for matched normal sample (blood)
  • Same as CLIA
Tissue / plasma
  • Plasma: 2 tubes of whole blood collected in Streck tubes (8-10mL per tube) for ctDNA; 6 mL whole blood collected in EDTA tube for matched normal WES analysis
  • Tissue: 12-20 unstained (charged and unbaked) 5 micron FFPE slides with >5mm2 tumor plus 1 H&E slide (≥20% tumor content)
  • Plasma: Down to 2 mL from different blood tube types
  • Tissue: >5-6 unstained 5 micron FFPE slides (>15mm2), Pre-extracted tumor or normal DNA, different matched normal sources (PBMC, buffy coat, normal tissue), or pre-sequenced WES/WGS data

Reach out about partnering


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

2Reinert 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.

3Birkenkamp-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.

4Coombes 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.

5Magbanua 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.