New Medicare Coverage: Signatera in NSCLC
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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
Recommended testing cadence: serial testing is key to catch relapse sooner
Baseline MRD status
Specimen Requirements:Tumor tissue + 1 EDTA Whole Blood (6 mL K2 or K3) + 2x Streck | Plasma (10 mL Tiger Top)
Does my patient need ACT?
Post-surgical Risk-Stratification
4 weeks post-op(+/- 2 weeks)
Is there cancer lurking?
Surveillance
Every 3 Months(every 6 months if date of surgery is unknown)
Is the treatment working?
IO Treatment Response Monitoring
Every 6 Weeks(every 6 months if date of surgery is unknown)
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 >100 peer-reviewed publications studying >30,000 patients across >30 tumor types1-6
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
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?
We’re here to help you find out
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