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Signatera™

Predict Immunotherapy Treatment Benefit As Early As Week 61

A personalized tumor-informed circulating tumor DNA assay covered by Medicare for immune checkpoint inhibitor (ICI) treatment response monitoring across all solid tumor types and stages of cancer.

Assess Immunotherapy Treatment Response

When used serially, the Signatera™ Molecular Residual Disease Test (MRD) quantifies circulating tumor DNA (ctDNA) over time to provide a real-time assessment of changes in disease burden during immunotherapy (IO) treatment.1

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INSPIRE Trial

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

Early Changes in ctDNA Levels Predict Treatment Benefit

Changes in ctDNA levels from baseline to week 6 (start of cycle 3) are predictive of immunotherapy benefit across cancer types.1

ctDNA Clearance at Any Time Correlates with Overall Survival

Overall survival was 100% in patients who experienced ctDNA clearance for at least one on-treatment time point.1

Review Real-World Case Studies

Is the treatment working? A patient with stage IV non-small cell lung cancer (NSCLC) who experienced early tumor progression during first-line immunotherapy treatment cancer color icon Read Case Study
Is the cancer actually progressing? A patient with stage IV melanoma with an indeterminate imaging result during immunotherapy treatment functional testing icon Read Case Study
Is the patient an exceptional responder? A patient with stage IV non-small cell lung cancer (NSCLC) who was able to discontinue immunotherapy treatment after a prolonged, durable, complete response functional testing icon Read Case Study

Watch How Signatera™ Informs Treatment Strategy

“Signatera™ gives us confidence with how we think about what’s going on with the patient … their prognosis and whether or not we are doing the right thing for them.”

Steven Liu, MD

medical oncologist

Know More With a Single Tumor Sample

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Bespoke IO Clinical Trial

The BESPOKE IO clinical study is currently enrolling patients living with colorectal cancer, non-small cell lung cancer, and melanoma who will receive standard of care treatment with ICIs. The study will determine how longitudinal Signatera™ testing impacts treatment decisions and early detection of disease progression when integrated as part of routine assessment of tumor response.

 

Natera and its collaborators will collect clinical utility and outcomes data for two years from patient enrollment. This data will help demonstrate how Signatera™ ctDNA test results correlate to responses to ICIs and how Signatera™ can help physicians and patients in treatment planning.

BESPOKE study of ctDNA guided immunotherapy (IO)

Learn More About Immunotherapy Monitoring

Dr. Luis Raez, Medical Director and Chief Scientific Officer of Memorial Cancer Institute in Florida, discusses ctDNA testing and how the personalized, tumor-informed Signatera™ assay can be used for immunotherapy response monitoring.

Get Started with Signatera™

Is Signatera™ right for your patients on immunotherapy?



References

1Bratman SV, et al. Personalized circulating tumor DNA analysis as a predictive biomarker in solid tumor patients treated with pembrolizumab. Nat Cancer. 2020;1:873–881. https://doi.org/10.1038/s43018-020-0096-5

2Haslam A, et al. Estimation of the percentage of US patients with cancer who are eligible for and respond to checkpoint inhibitor immunotherapy drugs. JAMA Netw Open. 2019;2(5):e192535-e192535. https://doi.org/10.1001/jamanetworkopen.2019.2535

3Haslam A, et al. Estimation of the percentage of US patients with cancer who are eligible for immune checkpoint inhibitor drugs. JAMA Netw Open. 2020;3(3):e200423. https://doi.org/10.1001/jamanetworkopen.2020.0423