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Covered by Medicare for Select Indications

Signatera

Transforming the management of cancer with personalized testing

Signatera™ is a highly sensitive and personalized molecular residual disease assay (MRD) using circulating tumor DNA (ctDNA), custom designed for each patient to help identify relapse earlier than standard of care tools.

Signatera™ Indications

Signatera™ can be used for a variety of cancer types. To learn more about how, please select one.

When to use Signatera™ MRD test?

Neoadjuvant Setting

  • To assess response to neoadjuvant therapy to help inform next steps

Adjuvant Setting

  • Use after surgery to evaluate the need for adjuvant chemotherapy and inform when to escalate or right-size treatment

Surveillance Setting

  • Detect MRD with greater sensitivity than current standard of care tools
  • Signatera™ is meant to be used serially to detect relapse earlier

Not all MRD assays are created equal

Considerations when choosing patient monitoring tools:

Comprehensive Comprehensive clinical validation
Demonstrated Demonstrated real-world experience
Personalized Personalized and tumor-informed
Validated
Extensively validated
Signatera™ has been validated in >100 peer-reviewed publications studying >30,000 patients across >30 tumor types1-6
Experience
Deep experience
Signatera™ has been used to manage over 250,000 patients and has been ordered by more than 40% of US oncologists6

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 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

Is Signatera™ right for your patients?

We’re here to help you find out

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References

1Reinert T, Henriksen TV, Christensen E, et al. JAMA Oncol. 2019. doi:10.1001/jamaoncol.2019.0528.

2Coombes RC, et al., Clin Cancer Res, 2019.

3Lebow, et al., Front. Oncol, 2023.

4Christensen E, et al. J Clin Oncol, 2019.

5Kotani D. et al, Nature Medicine, 2023.

6Data on file

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