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New Medicare Coverage: Signatera in NSCLC

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New Medicare Coverage: Signatera in NSCLC

Learn More
Medicare Icon
Covered by Medicare for patients with stage I-III NSCLC in the surveillance setting
Medicare Icon
Covered by Medicare for monitoring immunotherapy response in patients with any solid tumor

Signatera™ for Lung Cancer

Personalized, tumor-informed ctDNA molecular residual disease (MRD) testing to inform lung cancer care.

Detect and Monitor ctDNA in NSCLC to Inform Treatment Strategy

Test

Identify High Risk Patients

Test for presence of MRD after definitive therapy to assess prognosis1-2

27x

Higher risk of recurrence
for ctDNA positive patients1

Know

Detect Recurrence Earlier

Detect recurrence before
radiographic imaging1-2

5-6 months

Median lead time over
radiographic recurrence1-2

Decide

Monitor Immunotherapy
Treatment Response

Track early changes in ctDNA levels to predict outcomes3

96% lower

Risk of death for patients who cleared their ctDNA by week 9 compared to patients with increasing ctDNA3

Better Biomarkers are Needed to Optimize NSCLC Patient Care

Recurrence Chart

30-55% of NSCLC patients will develop disease recurrence post-definitive treatment (surgery; chemo-radiation)4

Guideline Icon

Guidelines for stage IB-IIA patients provide the option of either adjuvant systemic therapy or observation alone

Detection Icon

Early detection of recurrence with less tumor burden may enable local treatment with curative-intent, potentially improving outcomes5

Inform Your Lung Cancer Treatment Approach With Signatera™

Monitoring circulating tumor DNA (ctDNA) with Signatera™ across the treatment journey can answer important clinical questions and inform treatment decisions.

Response monitoring
Post-surgical MRD assessment
Recurrence monitoring
Response monitoring
Monitor response to neoadjuvant immunotherapy
Identify early-stage patients at high risk of recurrence to help inform adjuvant treatment strategies
Identify recurrence earlier than CT imaging
Inform early treatment escalation and clarify indeterminate imaging

Inform Your Lung Cancer Treatment Approach With Signatera™

Monitoring circulating tumor DNA (ctDNA) with Signatera™ across the treatment journey can answer important clinical questions and inform treatment decisions.

Response monitoring
Monitor response to neoadjuvant immunotherapy
Post-surgical MRD assessment
Identify early-stage patients at high risk of recurrence to help inform adjuvant treatment strategies
Recurrence monitoring
Identify recurrence earlier than CT imaging
Response monitoring
Inform early treatment escalation and clarify indeterminate imaging
Get Started

Identify High Risk Patients and Detect Recurrence Sooner

Signatera™ was evaluated in Martin et al 2024, a study in patients with stage I-II resectable NSCLC after surgical resection and during surveillance1

  • Sigantera™-positive patients had a 27x higher risk of recurrence than Signatera™-negative patients
  • Post-operative surveillance strategies were altered in 100% of ctDNA-positive patients (earlier radiographic imaging), and patients with PET scans positive for malignant features received early referrals for treatment
  • Signatera™ detected relapse with a 5.5-month median lead time to imaging-confirmed relapse and 98% NPV (negative predictive value)

Evaluate Response to ICI Treatment in NSCLC

Signatera™ was evaluated in the EMPower Lung-1 trial, a prospective study in patients with advanced or metastatic NSCLC randomized to immune checkpoint inhibitor (ICI) vs chemotherapy for 1L treatment3

  • Rising ctDNA by week 3 or lack of ctDNA clearance by week 9 identified patients experiencing inferior clinical outcomes
  • ctDNA deep decrease (>90%) and clearance were associated with significantly improved OS
  • Composite ctDNA & RECIST assessment may improve prediction of OS benefit from ICI

Watch to Learn More About Signatera™

See the Latest Data and How Signatera is Used to Personalize NSCLC Patient Care with Oleg Gligich, MD and Michael Krainock, MD, PhD

Reassure Your Patients Living With Lung Cancer

After JoAnn was diagnosed with lung cancer, Signatera™ detected a rise in her ctDNA levels, alerting her oncologist to a progression that was not scannable.

Watch JoAnn’s story to learn how she and her oncologist added Signatera™ testing to their toolbelt to help closely monitor her cancer.

“I want to know. The more you know, the better off you are.” – JoAnn, living with lung cancer

Do More With Less Tissue

One tumor sample – two tests

Add the Altera™ tumor genomic profiling test when you order Signatera™ to get clinically relevant biomarkers (eg EGFR, KRAS, ALK, ROS1, MSI, TMB) and MRD monitoring with no additional sample.

Lung Cancer Resources

The benefits of using ctDNA over traditional scans to assess responses to ICI

Dr. Natalie Vokes shares thoughts on how ctDNA can be used in addition to scans in NSCLC

Signatera IO Monitoring in Lung Cancer

Signatera™ in Lung Cancer

Learn about Signatera™ for risk-stratification, surveillance, and immunotherapy response monitoring

Patient Case Study

Read how Signatera™ detected a rise in ctDNA levels during immunotherapy, informing the decision to pivot to a combination therapy approach.

Ready to try Signatera™ for your lung cancer patients?

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*OS = Overall Survival

References

1Martin TK, Dinerman A, et al. Early Real-World Experience Monitoring Circulating Tumor DNA in Resected Early-Stage Non-Small Cell Lung Cancer. J Thorac Cardiovasc Surg. 2024. doi: 10.1016/j.jtcvs.2024.01.017.

2Lebow E, et al. ctDNA-based detection of molecular residual disease in stage I-III non-small cell lung cancer patients treated with definitive radiotherapy. Front. Oncol. 2023,13:1253629.

3Vokes N, Gandara D, et al. Circulating Tumor DNA (ctDNA) Dynamics and Survival Outcomes in Patients with Advanced NSCLC and High (greater than 50%) PD-L1 Expression, Randomized to Cemiplimab vs Chemotherapy. Presented at ASCO Annual Meeting, Chicago, IL, June 2023.

4Uramoto H, Tanaka F. Translational Lung Cancer Research. 2014;3:242–249

5Gomez DR, et al. J Clin Oncol 2019;37:1558-1565.

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