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Covered by Medicare for Select Indications

Signatera™ Genome:

Ultrasensitive ctDNA detection from the leaders in MRD testing

Detect and Monitor ctDNA to Inform Treatment Decisions

Test

Identify
High Risk Patients

Signatera™ Genome identified patients
with a

36x

higher risk of recurrence1

Know

Predict Benefit of
Adjuvant Treatment

Signatera™ Genome identified patients
with a

34%

increase in DRFS1

Decide

Detect
Recurrence Early

Signatera™ Genome detected distant, extracranial recurrence with

94%

sensitivity and 100% specificity1

Why Signatera™ Genome?

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Ultra-sensitive detection down to 1 part per million (PPM)¹

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Increased lead times to recurrence

Target icon

Enhanced sensitivity to detect recurrence

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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

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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)
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

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Stage II-IV and oligometastatic colorectal cancer (CRC) in the adjuvant and recurrence monitoring settings
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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
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Muscle invasive bladder cancer (MIBC) in the adjuvant and recurrence monitoring settings
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Stage I-III non-small cell lung cancer (NSCLC) in the surveillance setting
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Stage II-IV ovarian, fallopian tube, or primary peritoneal cancer in the adjuvant and recurrence monitoring settings
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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 Clinicans

>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

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References

1George M, et al. Poster presented at ASCO Annual Meeting, Chicago, IL, June 2025.

2Natera data on file.

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