Signatera™ Genome:
Ultrasensitive ctDNA detection from the leaders in MRD testing
Detect and Monitor ctDNA to Inform Treatment Decisions
Identify
High Risk Patients
Signatera™ Genome identified patients
with a
36x
higher risk of recurrence1
Predict Benefit of
Adjuvant Treatment
Signatera™ Genome identified patients
with a
34%
increase in DRFS1
Detect
Recurrence Early
Signatera™ Genome detected distant, extracranial recurrence with
94%
sensitivity and 100% specificity1
Why Signatera™ Genome?
Ultra-sensitive detection down to 1 part per million (PPM)¹
Increased lead times to recurrence
Enhanced sensitivity to detect recurrence
Backed by Signatera™ experience in >1M samples*
*>1M samples for Signatera™ designed on exome
Pan-cancer Signatera™ Genome data1
Signatera™ Genome was evaluated in a pan-cancer cohort of 392 patients with breast cancer, NSCLC, melanoma, RCC, and CRC across >2,600 plasma samples1
Identify High Risk Patients
- ctDNA status at the landmark time point was highly prognostic of patient outcomes
- ctDNA-positivity post-surgery was associated with significantly worse distant, extracranial relapse-free survival compared to ctDNA-negativity
Predict Adjuvant Treatment Benefit
- Patients who were ctDNA-positive after surgery derived a 34% increase in DRFS, while no treatment benefit was observed in ctDNA-negative patients
Detect Recurrence Early
- Signatera™ Genome detected distant, extracranial relapse with 94% longitudinal sensitivity and 100% specificity
- ctDNA-positive patients had a 36x higher risk of relapse than ctDNA-negative patients
- Serially ctDNA-negative patients achieved 100% 12-month DRFS vs just 41% for anytime ctDNA-positive patients
Signatera™’s mPCR-NGS approach
Sequences deeper on the most critical variants, providing the most personalized and clinically meaningful MRD signal
-
Ultra-deep sequencing (up to 350,000x coverage for each selected variant)2
-
Highly curated selection of 64 clonal variants for optimized balance of ultra-sensitivity and high specificity2
-
Proprietary variant selection and calling algorithms for bespoke MRD monitoring2
Natera has the most comprehensive portfolio on MRD solutions to support patient care
Signatera™ MRD Test
Most extensively validated, adopted, and reimbursed MRD assay available
Signatera™ Genome MRD Test
Lower limit of detection (LoD) for enhanced sensitivity and increased lead time to recurrence1
Latitude™ MRD Test
(available in Summer 2025)
(available in Summer 2025)
Tissue-free epigenomic assay with fast turnaround time for when tissue is not available
Same Signatera™ report; same sample requirements
- Patient report: contains the same look and feel as existing Signatera™ report
- Results will be identified as Signatera™ Genome
- TAT: For initial result (4 weeks); 7-10 day TAT for subsequent results
*Can only be ordered for new patients (unable to convert existing orders)
Covered by Medicare for multiple solid tumor indications
Stage II-IV and oligometastatic colorectal cancer (CRC) in the adjuvant and recurrence monitoring settings
Stage II-IV breast cancer in the neoadjuvant setting, regardless of subtype
Stage IIb and higher breast cancer in the adjuvant and recurrence monitoring settings
Muscle invasive bladder cancer (MIBC) in the adjuvant and recurrence monitoring settings
Stage I-III non-small cell lung cancer (NSCLC) in the surveillance setting
Stage II-IV ovarian, fallopian tube, or primary peritoneal cancer in the adjuvant and recurrence monitoring settings
For monitoring of response to immune-checkpoint inhibitor (ICI) therapy for patients with any solid tumor
Get Started
- Signatera™ has the same sample requirements whether designed on genome or exome
- Collect samples as usual and include the printed requisition in the kit
Signatera™ is the most extensively validated and widely adopted MRD assay
Widely Used by Clinicians
>1 million
Signatera™ tests ordered by EOY 20242
>300,000
Signatera™ patients2
>40%
of oncologists2
Extensive and Robust Clinical Evidence
>100
publications2
>260
congress presentations & posters2
>20
clinical studies prospectively using Signatera™2
Is Signatera™ Genome, right for your patients?
We’re here to help you find out
References
1George M, et al. Poster presented at ASCO Annual Meeting, Chicago, IL, June 2025.
2Natera data on file.