Skip navigation

Actionable molecular insights

Use SignateraTM in oncology clinical trials to build early evidence of efficacy and identify participants most likely to benefit from additional treatment1-5.

Assess disease at the molecular level

Signatera is a personalized, tumor-informed circulating tumor DNA (ctDNA) assay to detect and monitor molecular residual disease (MRD).

ONC_how it works_MD-01

Whole exome sequencing

Sequence tumor tissue and matched normal blood to identify tumor-specific genomic signatures

ONC_how it works_MD-02

Personalized assay design

Create custom multiplex PCR assay to target patient-specific clonal mutations in plasma

ONC_how it works_MD-03

Longitudinal monitoring 

Assess ctDNA levels over time to evaluate disease persistence, recurrence, and treatment response

Enrich for high-risk populations

  • Stratify & enrich for study participants most likely to benefit from additional treatment1-2
  • Treat on molecular relapse at time of lower disease burden

Benefits

  • Maximize therapy efficacy and decrease necessary study size
  • Move ahead of next-line therapies

Predict response sooner

  • Predict therapy response as early as 6 weeks3 into treatment
  • Support early therapy efficacy readouts as a co-primary or surrogate endpoint

Benefits

  • Improve program prioritization and planning
  • Accelerate approval of new therapies

Hear from experts: real world uses

Pharma and academic panelists discuss:

  • Experiences with ctDNA MRD testing in clinical trials
  • Considerations for incorporating ctDNA MRD testing
  • Future directions of ctDNA-guided trials

… ctDNA as a biomarker has a number of potential regulatory and clinical uses in the early stage setting that may assist and expedite drug development … to enrich a high- or low-risk population for study in a trial, to reflect a patient’s response to treatment, or potentially as an early marker of efficacy …”

FDA DRAFT GUIDANCE FOR INDUSTRY | USE OF CTDNA FOR EARLY-STAGE SOLID TUMOR DRUG DEVELOPMENT MAY 2022

Learn about Signatera data for each use case

ONC_how it works_MD-01

Enrich populations

Post-surgical ctDNA status identified study participants who benefited from an investigational adjuvant therapy1

ONC_how it works_MD-02

Monitor response

Early decrease in ctDNA levels at week 6 correlated with favorable outcomes in the metastatic setting3

ONC_how it works_MD-03

Supplement endpoints

ctDNA dynamics in neoadjuvant setting can potentially support pathologic complete response (pCR) as surrogate endpoint4

Leverage end-to-end expertise and insights

Natera Oncology integrates the power of Signatera ctDNA and real world data (RWD) to help inform drug development.

alt text

Drive decisions with real-world data (RWD)

Watch this webinar to learn how our partners can harness insights from:

  • Tumor-normal whole exome sequencing data matched to clinically complete records across 50+ cancer histologies
  • A comprehensive clinico-genomic datasets in early stage cancer
  • An extensive treatment response monitoring dataset in late stage cancer (particularly in IO)

How can Signatera support your clinical trials?

Contact us to learn more



References

1 Powles T, et al. ctDNA guiding adjuvant immunotherapy in urothelial carcinoma. Nature. 2021;595:432-437. https://doi.org/10.1038/s41586-021-03642-9

2Oki E, Shirasu H, Watanabe J, et al. Dynamics of circulating tumor DNA after resection of colorectal cancer: Galaxy study in Circulate-Japan. Oral presentation presented at SSO, Dallas, Texas, March 9-12, 2022

3 Bratman SV, et al. Personalized circulating tumor DNA analysis as a predictive biomarker in solid tumor patients treated with pembrolizumab. Nat Cancer. 2020.1:873-881. https://doi.org/10.1038/s43018-020-0096-5

4Magbanua MJM, et al. Circulating tumor DNA in neoadjuvant treated breast cancer reflects response and survival. Ann Oncol. 2021;32(2):229-239. https://doi.org/10.1016/j.annonc.2020.11.007

5Shoushtari, A, Collins, L, Arranz, E, et al. Early reduction in ctDNA regardless of best RECIST response, is associated with overall survival (OS) on tebentafusp in previously treated metastatic uveal melanoma (mUM) patients. Oral Presentation presented at ESMO GI; Sep 16-21, 2021. Abstract ID: 3600.

6 Christensen E, Birkenkamp-Demtroder K, Sethi H, et al. Early Detection of Metastatic Relapse and Monitoring of Therapeutic Efficacy by Ultra-Deep Sequencing of Plasma Cell-Free DNA in Patients With Urothelial Bladder Carcinoma. J Clin Oncol. 2019;37(18):1547-1557.