Covered by Medicare for patients with stage II-IV breast cancer

Signatera™ for Breast Cancer

Empower treatment decisions with tumor-informed molecular residual disease (MRD) testing

Future of Breast Cancer Management

This webinar features Dr. Fenting Yan from Fred Hutch and Dr. Jamie McKenzie from Natera discussing the latest Signatera™ breast cancer data presented at the San Antonio Breast Cancer Symposium (SABCS) in December 2025.

Watch on-demand webinar

Inform Decisions for High Risk Patients

Risk Stratify Patients

5.89x

Signatera™ identified early breast cancer patients with a 5.89x higher risk of recurrence after surgery, regardless of pCR status.¹

Predict Recurrence

52x

Identify patients at a significantly higher risk of recurrence; ctDNA positive patients are 52x more likely to recur than ctDNA negative patients.²

Longitudinal ctDNA status post-definitive treatment graph

Signatera™ Genome: The Trusted Leader in Ultra-Sensitivity

Signatera™ Genome provides unparalleled performance in detecting residual disease across all breast cancer subtypes.

Unmatched Accuracy: Validated 100% sensitivity and specificity across all subtypes, detecting ctDNA down to 1 ppm.
Earlier Detection: Identifies recurrence an average of 10.5 months ahead of imaging, allowing for proactive intervention.
Proven Risk Stratification: Positive results indicate a 221x higher risk of recurrence, with Medicare coverage for both neoadjuvant and surveillance settings.

What do I do with a patient who has detectable ctDNA?

Potential management options for patients with MRD.⁸

How often should I test?

Neoadjuvant Response Monitoring and Risk Stratification

Neoadjuvant Response Monitoring (I-SPY2 Trial)

Detail description about out technology

Signatera™ provides superior risk stratification during neoadjuvant treatment (NAT), identifying patients at highest risk for recurrence regardless of residual disease.

Predictive Early Clearance: Early ctDNA clearance (T1/T2) is a critical predictor of improved survival.
Superior Risk Stratification: In RCB-III tumors, ctDNA-negative patients achieved an 83% 3-year DRFS vs. only 22% for those remaining positive.
Refined Clinical Insight: Persistent T3 positivity identifies high recurrence risk even when conventional pathology shows residual disease.

Cancer Cell 2023 Nature Comm 2025

Adjuvant MRD Assessment & Surveillance Recurrence Monitoring

Monitoring during the adjuvant and surveillance settings provides refined risk stratification for patients on endocrine therapy. Prospective data from DARE and PALLAS show that genomic negativity identifies a large population with exceptionally low recurrence risk.

>99% NPV: DARE showed nearly 100% NPV for relapse in persistently negative patients.
HR 21.5: PALLAS demonstrated that positivity at EOT identifies a high-risk subgroup.

DARE Data PALLAS Data

Adjuvant MRD Assessment & Surveillance Recurrence Monitoring

IO Response & Metastatic Treatment Monitoring

Metastatic Therapeutic Response Monitoring

Detail description about out technology

Early on-treatment ctDNA dynamics serve as a powerful predictor of treatment efficacy and patient outcomes in advanced disease.

Predictive Value (reference: Razavi ASCO 2025): Favorable ctDNA dynamics correlate with longer Time to Next Treatment (TTNT) across all breast cancer subtypes.
Clinical Benefit (reference: Foldi Data):92% of patients with stable or decreasing ctDNA while on treatment demonstrated measurable clinical benefit.
IO & Metastatic Utility: Early ctDNA clearance by week 6 predicts superior OS and PFS for patients receiving immunotherapy and clarifies indeterminate imaging.

Razavi (ASCO 2025)INSPIRE Data

Comprehensive molecular insights across the breast cancer journey

Natera’s integrated portfolio combines the ultra-sensitivity of Signatera™ with the Breast STAT panel, Empower™, and Altera™ to provide a complete genomic picture for personalized treatment decisions.

Empower™

A hereditary cancer test that screens for genes associated with an increased risk for common hereditary cancers to guide personalized care and familial risk assessment.

Altera™

Comprehensive genomic profiling, delivering a deeper understanding of each cancer’s unique signature for targeted therapy selection.

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

Is Signatera™ for breast cancer right for your patients?

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References

*Based on surveillance guidelines; cadence is suggested based on utility of other providers in this indication but does not replace clinical judgment or guidance as set forth in your institutions.

¹ Magbanua MJM et al. Clinical significance and biology of circulating tumor DNA in high-risk early-stage HER2-negative breast cancer receiving neoadjuvant chemotherapy. Cancer Cell. 2023; 41(1):1–12.

² Cutts R et al. Detection of ctDNA following surgery predicts relapse in breast cancer patients receiving primary surgery. Presented at SABCS; Dec 7–11, 2021.

³ Shaw JA, Page K, Wren E, et al. Serial postoperative circulating tumor DNA assessment has strong prognostic value during long-term follow-up in patients with breast cancer. JCO Precis Oncol. 2024; 8:e2300456. doi:10.1200/PO.23.00456.

⁴ Bratman SV et al. Nat Cancer. 2020; 1(9):873–881.

⁵ Early Breast Cancer Trialists’ Collaborative Group. Lancet. 2005; 365:1687–1717.

⁶ O'Connor T et al. Clin Adv Hematol Oncol. 2013; 11(6):341–347.

⁷ Magbanua MJM et al. Ann Oncol. 2021; 32(2):229–239.

⁸ Magbanua MJM et al. Comparison of the predictive and prognostic significance of circulating tumor DNA in patients with high-risk HER2-negative breast cancer receiving neoadjuvant chemotherapy. Presented at AACR; Apr 8–13, 2022.

⁹ Coombes RC et al. Clin Cancer Res. 2019 Jul 15; 25(14):4255–4263.

¹⁰ Pusztai L et al. Circulating tumor DNA (ctDNA) monitoring of ER+/HER2- high-risk breast cancer during adjuvant endocrine therapy. Presented at ASCO Annual Meeting; 2025. Abstract 1010.

¹¹ Razavi P et al. Circulating tumor DNA (ctDNA) dynamics as a predictor of treatment response in metastatic breast cancer. Presented at ASCO Annual Meeting; 2025. Abstract 1011.

¹² George et al. Clinical performance of Signatera Genome assay in a cohort of patients with solid tumors. Poster presented at ASCO Annual Meeting; Chicago, IL; 2025. Abstract 3142.

¹³ McHayleh et al. Poster presented at SABCS; 2025. Poster PS2-07-26.

¹⁴ Parsons et al. Poster presented at SABCS; 2025.

¹⁵ Medford A et al. LEADER study. Presented at SABCS; 2025.

¹⁶ Xu et al. Presented at SABCS; 2025.

¹⁷ Carleton, Neil, et al. “Use of ctDNA in Older Women with ER+ Breast Cancer to Facilitate Surgical De-escalation: A Prospective, Hybrid-Decentralized Trial with Correlative Studies.” Clinical Cancer Research, 2026.

¹⁸ Foldi, J., et al. (2025). Personalized Circulating Tumor DNA Testing for Detection of Progression and Treatment Response Monitoring in Patients With Metastatic Invasive Lobular Carcinoma of the Breast. JCO Precision Oncology, 9, e2400577.