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
| PARTNER | INDICATION | PHASE | PRESS RELEASE |
|---|---|---|---|
| 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 |
| Institute 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 |
| NRG Oncology CIRCULATE-US | Colorectal Cancer | Phase 2/3 | READ MORE |
| AMAL Therapeutics – KISIMA-01 trial | Colorectal Cancer | Phase 1b | READ MORE |
| Arhaus University | Colorectal Cancer | RUO | READ MORE |
| Natera – BESPOKE trial | Colorectal Cancer | Registry trial | READ MORE |
| NCC Japan – CIRCULATE-IDEA trial | Colorectal Cancer | Registry trial | READ MORE |
| Fox Chase Cancer Center | Kidney cancer | RUO | READ MORE |
| Bristol-Myers | Lung cancer | Phase 2 | READ MORE |
| Neon Therapeutics – NEO-PV-01 trial | Lung cancer | Preclinical | READ MORE |
| Elicio Therapeutics – ELI-002 trial | Pancreatic ductal adenocarcinoma (PDAC) |
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?
Reach out to learn if Signatera CLIA or Signatera RUO is right for your clinical trial
Natera Oncology works on registrational clinical trials as well as retrospectively batched samples studies. The translational science and medical teams at Natera can support data analysis, provide trial-setup recommendations and provide guidance based on previous work.
Reach out about partnering
References
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.