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Know earlier if ICI treatment is working

During treatment with immune-checkpoint inhibitors (ICI), you want answers to critical questions as soon as possible.

  • Is the treatment working?
  • Is the tumor truly progressing?
  • Should you change or restart treatment?

Signatera is a personalized tumor-informed assay for ultrasensitive detection of molecular residual disease (MRD) using circulating tumor DNA (ctDNA) to assess treatment response in conjunction with standard imaging.

Signatera is covered by Medicare for immunotherapy treatment response monitoring across all tumor types and stages of cancer.


The challenges of ICI treatment.
The power of ctDNA.

Despite dramatic improvements in cancer care using antibodies that block the immune checkpoint proteins CTLA-4, PD-1, or PD-L1, the reality is ICI-based treatments don’t work for everyone:

  • About 43.5% of cancer patients are eligible for ICI treatment.1,2
  • Less than 20% of eligible patients will derive sustained response or clinical benefit to ICIs.1,2

Early and ultrasensitive monitoring of tumor progression is key to improving patient outcomes in the immuno-oncology (IO) setting. Existing methods, including CT scans and serum protein biomarkers, are unreliable in this regard.

Use Signatera in your practice to evaluate IO treatment response earlier than CT scans and serum protein biomarkers

Is the treatment working? Read more about a stage IV non-small cell lung cancer (NSCLC) patient who experienced early tumor progression during first-line immunotherapy treatment cancer color icon Read Flipbook
Is the tumor truly progressing? Read more about a stage IV melanoma patient with an indeterminate imaging result during immunotherapy treatment functional testing icon Read Flipbook
Is there a need to change or reinitiate treatment? Read more about a stage IV non-small cell lung cancer (NSCLC) patient who was able to discontinue immunotherapy treatment after a prolonged, durable, complete response functional testing icon Read Flipbook

Hear how Signatera helped guide Jeffrey’s treatment plan

“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

INSPIRE Trial: Validating ctDNA as an early biomarker of ICI treatment response

Signatera was evaluated in the INSPIRE trial, a randomized, prospective study in patients with advanced or metastatic solid malignancies receiving an anti-PD-1 therapy.7

  • 98% of patients had detectable ctDNA at baseline
  • An increase in ctDNA levels from baseline at week 6 strongly predicted disease progression and non-response to an anti-PD-1 therapy
  • Achieving ctDNA clearance at any time during treatment correlated with durable OS

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

Positive Result

BESPOKE study of ctDNA guided immunotherapy (IO)

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 ICIs. The study will determine how routine 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 outcome data for two years from patient enrollment. This data will help better understand 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 assay Signatera can be used for immunotherapy response monitoring.

Check out our FAQs to learn more about Signatera

Questions about Signatera? Submit your inquiries here.


1Haslam A, Prasad V. JAMA Network Open. 2019;2(5):e192535-e192535.

2Haslam A, Gill J, Prasad V. JAMA Netw Open. 2020;3(3):e200423. doi:10.1001/jamanetworkopen.2020.0423

3Reinert T, Henriksen TV, Christensen E, et al. JAMA Oncology. 2019;5(8):1124-1131.

4Coombes C, Page K, Salari R, et al. Clinical Cancer Research. 2019;25(14):4255-4263.

5Abbosh C, Birkbak N, Wilson GA, et al. Nature. 2017,545:446–451

6Christensen E, Birkenkamp-Demtröder K, Sethi H, et al. 2019; 37(18):1547-1557.

7Bratman SV, Yang SYC, Iafolla MAJ, et al. Nat Cancer. 2020;1:873–881.