ctDNA-MRD testing has the potential to play an important role across the lymphoma patient journey
Newly Diagnosed Setting
- ctDNA clearance measured at any point during frontline therapy is prognostic for event free survival (EFS) and overall survival (OS)
- NCCN Guidelines® recommend consideration of ctDNA testing for the EOT PET-positive scenario and if the biopsy is not feasible
Relapsed/Refractory Setting
- Identify MRD-positive patients to help inform subsequent treatment decisions
Surveillance Setting
- Serial monitoring enables early detection of recurrence with greater sensitivity than imaging
How Signatera™ Works: a personalized and tumor informed approach to MRD surveillance
Personalized, tumor-informed assay
One-time, primary tissue sample and matched normal sample is required for whole exome or whole genome sequencing and personalized test design.
Ultrasensitive ctDNA detection
Signatera™ is designed to detect ctDNA of somatic and truncal variants to optimize sensitivity. Tumor-informed method enables filtering of CHIP mutations to decrease false positive rates.
Optimized for longitudinal monitoring
Once the patient’s personalized test has been designed, only a blood sample is needed each subsequent time.
Study overview: Real-world evaluation of ctDNA for risk stratification across the spectrum of both aggressive and indolent lymphomas
This study analyzed prospectively collected, real-world data of MRD detection and ctDNA clearance kinetics in patients with either newly diagnosed or relapsed/refractory lymphoma across 14 subtypes, including a subset of patients who received CAR-T cell therapy.
Study Findings
- Definitive relapse prediction: Signatera™ achieves 100% positive predictive value (PPV) for lymphoma relapse at end of treatment (vs. 64% PPV for PET/CT)
- Enhanced risk stratification: ctDNA provides nearly 6x stronger relapse prediction than PET-CT
- Superior prognostic clarity: Signatera™ delivers superior treatment response prediction independent of PET-CT status
ctDNA clearance at any point during frontline therapy was found to be prognostic for improved survival outcomes
Signatera™ has demonstrated high clinical sensitivity (89%) and specificity (94%) in real-world settings for early, personalized insights into treatment efficacy, relapse risk, and residual disease.
Not all MRD assays are created equal
Considerations when choosing patient monitoring tools:
Comprehensive clinical validation
Demonstrated real-world experience
Personalized and tumor-informed
To get started, send in your Signatera™ requisition form, sign in to the online portal or talk to your sales representative.
Step 1
Send tumor block or slides to prepare the personalized tumor-informed assay
Step 2
Complete information on tube labels
Step 3
Place filled and labeled tubes into the absorbent sleeve and into the metallic envelope. Place the metallic envelope into the biohazard bag.
Is Signatera™ in lymphoma right for your patients?
We’re here to help you find out
1Narkhede M, Tomassetti S, Iqbal M. Tumor-informed ctDNA assessment as a valuable prognostic and predictive biomarker in diffuse large B-cell lymphoma. Frontiers in Oncology. July 28, 2024; Section: Hematologic Malignancies. Volume 14 – 2024.