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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.

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
Signatera high sensitivity and specificity
“Detecting relapse before it becomes clinically symptomatic requires a test with high sensitivity and specificity. Signatera™ enables us to confidently identify patients with molecular relapse when the disease burden is so low that it is undetectable with imaging.”
Lajos Pusztai, MD, DPhil

Lajos Pusztai, MD, DPhil

Professor of Medicine (Medical Oncology); Co-Leader, Genetics, Genomics and Epigenetics Research Program, Yale Cancer Center, Yale School of Medicine

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 >65 peer-reviewed publications studying >6,500 patients across >25 tumor types1-6
Experience
Deep experience
Signatera™ has been used to manage over 200,000 patients and has been ordered by more than 1/3 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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