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The signal that changes everything

Signatera™ Genome is the only MRD test capable of tracking Phased, Structural, and Single Nucleotide Variants, with market-leading detection demonstrated below 0.1 PPM.1

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Redefining the standard for ultrasensitive MRD

  • <1 PPM

    LOD95 (lowest level detected with 95% probability)1

  • <0.1 PPM

    Observed limit of detection1

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Phased and Structural Variants lower background error rate, enabling
market-leading detection below 0.1 PPM1,2


  • Clonal SNVs

    Clonal single nucleotide variants shown on a DNA helix

  • Phased Variants

    Phased variants shown on a DNA helix

  • Structural Variants

    Structural variants shown on a DNA helix

Higher prevalence

Lower prevalence

Lower error suppression

Higher error suppression

  • Probability of error

    1/10K

  • Probability of error

    1/100M

  • Probability of error

    <1/100M

Higher prevalence


  • Clonal SNVs

    Clonal single nucleotide variants shown on a DNA helix

    Probability of error

    1/10K


  • Phased Variants

    Phased variants shown on a DNA helix

    Probability of error

    1/100M


  • Structural Variants

    Structural variants shown on a DNA helix

    Probability of error

    <1/100M

Lower prevalence

The Signatera Genome assay combines all three variant classes in a single assay, personalized to the unique biology of each histology.3

Signatera Genome with Phased and Structural Variants


  1. Identify tumor-specific variants

    Whole Genome Sequencing of
    tumor + matched normal

    Tumor tissue Germline sample

  2. Design Personalized Assay

    Custom assay targeting patient-specific PVs, SVs, and SNVs

    • SNVsSingle nucleotide variants shown on a DNA helix
    • Phased Variants (PVs)Phased variants shown on a DNA helix
    • Structural Variants (SVs)Structural variants shown on a DNA helix

  3. Track ctDNA over time

    Serial plasma monitoring using the patient-specific assay

    Chart of mean tumor molecules per mL falling to non-detectable after surgery and treatment, tracked by serial ctDNA plasma tests

Breaking barriers in clinical performance

Signatera status was prognostic during post-1L surveillance4

Kaplan-Meier chart of event-free survival over months after end of treatment: ctDNA-MRD-negative patients stay at 100% while ctDNA-MRD-positive patients decline; bar chart shows 21 of 21 ctDNA-MRD-negative patients relapse-free versus 11 of 13 ctDNA-MRD-positive patients relapsing (Fisher's p-value below 0.0001).

100%

of relapses cases identified4

Up to

10 months

lead time4

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Applications in clinical development

Lower detection thresholds for higher-confidence decisions


  • Broader patient selection

    Lower detection thresholds for higher-confidence decisions


  • Deeper response assessment

    Greater confidence in ctDNA clearance for earlier
    efficacy assessment

Enable new trial opportunities

Updates & resources

Webinar

Signatera Genome: Unlocking the next level of ultrasensitive MRD detection with Phased Variant technology

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Article

The signal that changes everything: understanding MRD in oncology drug development

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Press Release

Natera Expands Precision Diagnostics Portfolio for Biopharma at ESMO Congress 2026

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Access technical and clinical performance data, or schedule a consultation for your assay design and trial strategy.

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References

  1. Analytical limit of detection demonstrated by Signatera Genome in a cell line dilution study. Signatera Genome with PVs and SVs available as a Research Use Only (RUO) assay. Natera data on file.
  2. Data Source: Kurtz et al. Nature Biotechnol 2021, Isbell et al. AACR Annual Mtg 2023, Cabel et al. ESMO Annual Mtg 2024. Error rates shown are for hybrid capture-based sequencing
  3. Natera internal data, as of Jan 2026
  4. William B, Galanina N, Iqbal M, et al. ctDNA-Based MRD as a Dynamic Biomarker for Monitoring Treatment Response and Relapse in Lymphoma. SOHO 2026 Annual Meeting, Houston, TX, September 9-12, 2026

The tests described have been developed and their performance characteristics determined by the CLIA-certified laboratory performing the test.
The tests have not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.
© 2026 Natera, Inc. All Rights Reserved.

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