Medical Tests

Signatera™ for Immunotherapy Monitoring

Tumor-informed ctDNA testing

Signatera^™ for immunotherapy treatment response monitoring

Covered by Medicare, Signatera^™ is custom-designed for each patient's unique tumor biology, to monitor immunotherapy response with precision in real-time across all stages of cancer.

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Covered by Medicare Monitoring immunotherapy response in patients with any solid tumor

98% of patients with an increase in ctDNA at the beginning of cycle 3 did not derive an objective response to immunotherapy treatment.¹

100% OS in patients who cleared ctDNA for at least one on-treatment time point.¹

Evaluate treatment response sooner

Serial ctDNA assessment may add molecular insight during immunotherapy

Signatera^™ is designed to longitudinally monitor molecular disease burden for patients on immunotherapy. Serial ctDNA assessment may provide an additional layer of insight alongside imaging and clinical evaluation, including treatment response monitoring in real time, clarifying indeterminate findings, and identifying molecular progression earlier.

Predict response

After just 2 cycles

98% of patients with an increase in ctDNA at the beginning of cycle 3 did not derive an objective response to immunotherapy treatment.¹

Identify exceptional responders

ctDNA clearance can support response assessment

100% OS in patients who cleared ctDNA for at least one on-treatment time point, with median follow-up beyond first clearance of 25.4 months.¹

Longitudinal monitoring

Helping answer critical questions during IO treatment

Signatera^™ quantifies ctDNA over time to provide a real-time assessment of changes in disease burden during immunotherapy treatment.¹

Is the treatment working?
Should treatment be changed or escalated?
Is the cancer actually progressing?
Is the patient an exceptional responder?

Longitudinal ctDNA monitoring questions during immunotherapy treatment

Treatment response monitoring data

Discover the treatment response monitoring data

Published studies support ctDNA dynamics as an early biomarker for response assessment and monitoring across multiple immunotherapy settings.

Solid tumors Melanoma NSCLC

Study 01 · INSPIRE trial

Predict immunotherapy response across solid tumors

The INSPIRE trial validated Signatera^™ ctDNA testing as an early biomarker of immunotherapy response with 98% baseline ctDNA detection across 94 patients and 25 solid tumor types.¹

98% baseline detection 94 patients 25 solid tumor types

INSPIRE trial ctDNA response monitoring charts

Melanoma ctDNA clearance and progression-free survival charts

Study 02 · Melanoma

Inform risk-based treatment selection and monitor immunotherapy response

69 advanced melanoma patients were monitored across 555 plasma timepoints to determine if ctDNA can help risk-stratify patients for disease recurrence and predict response to immunotherapy.²

69 patients 555 plasma timepoints

NSCLC overall survival by ctDNA status charts

Study 03 · NSCLC

Inform early treatment escalation on immunotherapy

Signatera^™ was evaluated in the EMPower Lung-1 trial, a prospective study in patients with advanced or metastatic NSCLC randomized to ICI versus chemotherapy for first-line treatment.³

EMPower Lung-1 1L treatment

Clinical support

Is Signatera^™ right for your patients on immunotherapy?

Our team can help patients and healthcare providers understand test access, coordination, and next steps.

References

Bratman SV, Yang SYC, Iafolla MAJ, et al. Personalized circulating tumor DNA analysis as a predictive biomarker in solid tumor patients treated with pembrolizumab. Nature Cancer. 2020;1(9):873-881.
Eroglu Z, Krinshpun S, Kalashnikova E, et al. Circulating tumor DNA based molecular residual disease detection for treatment monitoring in advanced melanoma patients. Cancer. 2023. https://doi.org/10.1002/cncr.34716.
Vokes N, et al. Circulating Tumor DNA (ctDNA) Dynamics and Survival Outcomes in Patients with Advanced NSCLC and High (>50%) PD-L1 Expression, Randomized to Cemiplimab vs Chemotherapy. Presented at ASCO Annual Meeting, Chicago, IL, June 2023.
Powles T, Assaf ZJ, Davarpanah N, et al. ctDNA guiding adjuvant immunotherapy in urothelial carcinoma. Nature. 2021.
Powles T, Assaf ZA, Degaonkar V, et al. Updated Overall Survival by Circulating Tumor DNA Status from the Phase 3 IMvigor010 Trial: Adjuvant Atezolizumab Versus Observation in Muscle-invasive Urothelial Carcinoma. European Urology. 2023. https://doi.org/10.1016/j.eururo.2023.06.007.

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Signatera™ Initial

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...

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