Setting the standard for MRD testing
Signatera™ is a highly sensitive and tumor-informed molecular residual disease assay (MRD) using circulating tumor DNA (ctDNA), custom designed for each patient to help inform meaningful intervention.
The most comprehensively validated and widely used MRD assay available
Deepest validation
>100 peer-reviewed publications studying >34,000 patients across >30 tumor types.1
Broadest patient access
Covered by Medicare for certain patients with CRC, breast cancer, MIBC, ovarian cancer, and pan-tumor IO monitoring.
Most established experience
Ordered by >40% of US oncologists for >250,000 patients.1
Reliable service and support
90% of initial Signatera™ reports are provided within 3 weeks and 90% of subsequent reports are provided within 1 week.1
Identify patient at a high risk of recurrence
- Recent data published in Nature Medicine (Sept 2024) included an interim analysis of the CIRCULATE-Japan GALAXY observational study demonstrating the association of circulating tumor DNA (ctDNA)-based molecular residual disease (MRD) detection with recurrence risk and benefit from adjuvant chemotherapy (ACT) in resectable colorectal cancer (CRC).
- This updated analysis included 2,240 patients with stage II–III colon cancer or stage IV CRC, reinforcing the prognostic value of Signatera™.
High risk stage II/IIII ctDNA positive patients were shown to be ~14x more likely to recur
ctDNA status in the MRD window
- 36-month OS was 96% in ctDNA negative patients vs. 71.8% in ctDNA positive patients
- ctDNA-positivity at the MRD time point was predictive of inferior OS
Treatment benefit in ctDNA positive patients
ctDNA-positivity significantly outperformed all other risk factors and was highly prognostic of DFS and OS
Within the MRD window, no statistically significant benefit from ACT was observed among MRD-negative patients; conversely, Signatera™-positive patients derived significant benefit from ACT
Evaluation of benefit of adjuvant chemotherapy (High risk stage II/III)
- The poster presented at ESMO 2024 reported that high-risk stage II and stage III-IV patients who were Signatera™-positive after surgery and received ACT demonstrated superior OS (adj HR: 0.53, p-value = 0.05)
- Signatera™ status was predictive of an overall survival benefit from adjuvant chemotherapy:
Informing treatment decisions along the continuum of care
Use Signatera™ after surgery to evaluate the need for adjuvant chemotherapy.
Use Signatera™ alongside CEA and imaging to detect recurrence earlier.
Assess a patient’s response to treatment in the neoadjuvant, adjuvant or immunotherapy settings.
Identify high risk patients with progressive disease who may benefit from earlier intervention or additional imaging.
Impact of ctDNA clearance in Signatera positive patients
- Sustained ctDNA clearance in response to ACT was an indicator of favorable DFS, compared to transient clearance (24-month DFS: 89.0% vs 3.3%.)
- Superior DFS was achieved with sustained clearance compared to transient or no clearance
DFS stratified by ctDNA clearance in patients with ctDNA positivity in the MRD window
MRD-positive patients who achieved sustained clearance had 100% OS at 24 month
OS stratified by ctDNA clearance in ctDNA positive patients in the MRD window
- For recurrent patients with transient clearance, 96% of patients converted positive by 18 months post–surgery
- This highlights the utility of longitudinal ctDNA monitoring in predicting long-term benefit of ACT and the need for repeat testing once systemic therapy is complete.
Clinical Application
The value of serial testing in the surveillance setting ctDNA status during surveillance was significantly associated with DFS
Clinical applications of ctDNA testing
Fine tuning chemotherapy
As we have seen in the recently presented data, patients who do not clear their ctDNA are at an increased risk of recurrence. Listen in how one providers incorporates Signatera™ into to his practice with the goal to impact patient care.
Tracks Disease Burden Over Time via ctDNA Dynamics
- Signatera™ is designed to accurately detect residual disease with an ultra-low level of detection (0.01% MTM/mL)
- Real time ctDNA analysis can help inform important adjuvant therapy decisions
- Signatera™ can also track ctDNA dynamics so you can gain real-time insight of disease burden.
Facilitating shared-decision making
Listen in to Keith’s incredible story about how he and his provider used Signatera™ to help inform next steps in his treatment journey.
Is Signatera right for your patients?
We’re here to help you find out
References
1Reinert T, Henriksen TV, Christensen E, et al. Analysis of Plasma Cell-Free DNA by Ultradeep Sequencing in Patients With Stages I to III Colorectal Cancer. JAMA Oncol. 2019.
2Coombes RC, Page K, Salari R, et al. Personalized Detection of Circulating Tumor DNA Antedates Breast Cancer Metastatic Recurrence. Clin Cancer Res. 2019;25(14):4255-4263.
3Abbosh C, Birkbak NJ, Wilson GA, et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017;545(7655):446-451.
4Christensen 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.
5Kotani D. et al., Molecular residual disease and efficacy of adjuvant chemotherapy in patients with colorectal cancer, Nature Medicine v29 Issue 1 Jan 2023