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

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 clinical validation

Demonstrated real-world experience

Personalized and tumor-informed

Extensively validated

Signatera™ has been validated in >85 peer-reviewed publications studying >6,500 patients across >25 tumor types^1-6

Deep experience

Signatera™ has been used to manage over 230,000 patients and has been ordered by more than 40% of US oncologists⁶

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 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™ right for your patients?

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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

Signatera™