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

Signatera™ for Breast Cancer

Personalized, tumor-informed ctDNA molecular residual disease (MRD) testing for breast cancer to inform critical decisions for care.

Inform Decisions for High Risk Patients


Risk-Stratify Patients

Identify patients with residual disease after surgery who may benefit from adjuvant treatment for high risk individuals


higher risk of distant metastasis in patients with molecular residual disease (MRD) after surgery1


Detect Recurrence Earlier

Use Signatera™ serially to monitor and identify breast cancer patients at high risk of recurrence2


higher risk of relapse in ctDNA positive versus ctDNA negative patients


Assess Treatment Response

Track changes in ctDNA levels to evaluate treatment response3

6 weeks

to understand response to immunotherapy treatment3

Get Started

Detect Recurrence Earlier in High Risk Patients

Despite significant improvements in care over the past few decades, up to 30% of women with no evidence of disease after curative intent treatment will eventually relapse and succumb to their disease.4 Existing tools are inadequate at identifying recurrence early before the patient becomes symptomatic, and 10-15% of patients experience reduced performance status at recurrence, which limits treatment options.5

Longitudinal testing with the Signatera™ Residual Disease Test has been shown to identify patients at high risk of recurrence with 88% sensitivity and a median of 10.5 months (range 0-38 months) ahead of imaging2, allowing for potential intervention.

Inform Questions Across Breast Cancer Treatment

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Explore the Peer-Reviewed Data in Breast Cancer

Neoadjuvant Response Monitoring and Risk Stratification

I-SPY 2 Study Schema

I-SPY 2 Studies: Can ctDNA Refine pCR as a Surrogate Endpoint for Survival?

For patients treated with neoadjuvant therapy, achieving a pathologic complete response (pCR) generally denotes a favorable prognosis. However, how can providers risk-stratify patients who have residual disease?

I-SPY 2 ctDNA Objectives

  • Evaluate ctDNA as a biomarker for monitoring response to neoadjuvant therapy6,7
  • Assess prognostic value of ctDNA in stratifying patients for risk of early metastatic recurrence6,7

The I-SPY 2 Platform Master Protocol

RNA Analysis
  • Response to neoadjuvant chemotherapy (NAC) and investigational treatments assessed through ctDNA dynamics at four time points
  • ctDNA derived from plasma was assessed at four time points: pretreatment (T0), 3 weeks after paclitaxel/study drug initiation (T1), between
    paclitaxel/study drug and anthracycline regimens (T2), and prior to surgery (T3).

I-SPY 2 Results

pCR and ctDNA status Can Help Risk-Stratify Patients6,7

RNA Analysis

At T3 across subtypes:

  • Patients who achieved a pCR and cleared their ctDNA had the best survival outcomes; those who did not achieve a pCR and were ctDNA positive
    had the worst outcomes.1–3
  • Regardless of pCR status, persistent ctDNA positivity by T3 was associated with shorter DRFS compared to ctDNA negativity.1–3

Learn More

Adjuvant MRD Assessment

Risk stratify patients after surgery to help identify those with residual disease who may benefit from intensified or extended adjuvant treatment

The EBLIS Study:

ctDNA status in conjunction with existing tools after surgery and adjuvant chemotherapy identified high risk patients with poor recurrence-free survival8 who may benefit from adjuvant treatment for high risk individuals

Relapse free Survival by ctDNA

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The I-SPY 2 Study:

Prior to surgery, the I-SPY 2 study showed that lack of ctDNA clearance regardless of pCR status identified patients with poor response to neoadjuvant chemotherapy and a high risk of recurrence6, which can help inform adjuvant treatment decisions

pCT and ctDNA Status at T3

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The Early Breast Cancer Study:

48 early stage breast cancer patients receiving primary surgery included in analysis (40 also received chemotherapy), with 144 total plasma samples; median follow up time 5 years (0.5-6)1

Surgery Adjuvant Chemo
  • 38% of patients who were ctDNA positive after surgery relapsed, while the remaining possibly benefited from adjuvant therapy.1
  • Detection of ctDNA after surgery was associated with worse outcomes compared to no ctDNA detection (DMFS HR: 5.6; 95% CI: 1.1-29.3; P=0.04)1
  • These data suggest that although MRD positivity post-surgery is prognostic of patient outcomes, it may be modifiable with adjuvant therapy.1

After Surgery (before adjuvant therapy)

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Surveillance Recurrence Monitoring

The EBLIS Study: Is there a more sensitive technology that can detect recurrence earlier?

The Exploratory Breast Lead Interval Study (EBLIS) explored the potential use of ctDNA monitoring in patients with high risk breast cancer in the longest ctDNA follow up study to date.2

EBLIS Protocol

RNA Analysis

EBLIS Results

Signatera™ can be used serially to monitor and identify breast cancer patients at high risk of recurrence

RNA Analysis

  • Longitudinal testing with Signatera™ identified ctDNA positive patients with a 52X higher risk of relapse compared
    to ctDNA negative patients
  • 88% sensitivity: Signatera™ detected ctDNA in 30 out of 34 patients before clinical or radiologic relapse
  • 10.5 months median lead time over radiographic recurrence (range 0-38 months)2

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Assess Immunotherapy Response

The INSPIRE Study: Can ctDNA be Validated as an Early Biomarker of ICI Treatment Response?

Despite dramatic improvements in cancer care using antibodies that block immune checkpoint proteins, less than 20% of eligible patients will derive sustained response or clinical benefit to immune checkpoint inhibitors (ICIs).7 How can ctDNA accurately identify those patients who are benefiting from ICI treatment?

INSPIRE Objectives

The prospective phase II INSPIRE trial addressed clinically relevant issues related to monitoring response to ICIs by assessing baseline ctDNA status and ctDNA dynamics.

INSPIRE Protocol

RNA Analysis


Signatera™ predicts immunotherapy benefit as early as week 6.3

Baseline ctDNA concentration and ctDNA dynamics during treatment correlated with progression-free survival, overall survival, clinical response, and clinical benefit.3

  • A decrease in ctDNA levels from baseline to the beginning of cycle 3 is a strong predictor of increased OS and PFS.3
  • Clearance of ctDNA at any time point resulted in superior clinical outcomes. All 12 patients who cleared ctDNA for at least one on-treatment time point remained alive during follow-up period (median follow-up beyond first clearance of 25.4 months)3
Comparison of Negative Predictive Values (NPV)

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Guiding the Breast Cancer Patient Journey

Angela’s Story

Like many patients, Angela has faced many questions throughout her journey with high risk breast cancer – what’s the next step in my treatment? Is the cancer ever going to come back? What’s causing this symptom?

Listen to the story of how she and her doctor use Signatera™ to help monitor for recurrence and treatment response, giving Angela the peace of mind to move on with her life.

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Medicare Coverage

Signatera™ is covered by Medicare for monitoring disease progression, disease recurrence, or relapse for patients with:
  • Stage II-IV and oligometastatic colorectal cancer (CRC) in the adjuvant and recurrence monitoring settings
  • Muscle invasive bladder cancer (MIBC) 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
  • 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

Commercial Insurance

We welcome all insurance plans.

We will work with patients so that cost is not a barrier for testing.

We offer an affordable self-pay rate for those patients who do not wish to use insurance.

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1Cutts R, et al. Detection of ctDNA following surgery predicts relapse in breast cancer patients receiving primary surgery. SABCS; December 7-11, 2021.

2Shaw JA, et al. Serial postoperative ctDNA monitoring for early detection of breast cancer recurrence. ASCO; June 3-7, 2022.

3Bratman SV, et al. Nature Cancer. 2020;1(9):873-881.

4Early Breast Cancer Trialists’ Collaborative Group. Lancet. 2005;365:1687-1717.

5O'Connor T, et al. Clin Adv Hematol Oncol. 2013;11(6):341-347.

6Magbanua MJM, et al. Ann Oncol. 2021; 32(2):229-239.

7Magbanua 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. AACR; April 8-13, 2022.

8Coombes RC, et al. Clin Cancer Res. 2019 Jul 15;25(14):4255-4263.

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