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Covered by Medicare for Select Indications

Signatera™

Transforming the management of cancer with personalized testing

As pioneers and trusted leaders in the MRD testing space, Signatera™ has been characterized in >100 peer-reviewed publications and with now >200K patients tested. With this unrivaled clinical validation and real-world experience, clinicians can feel confident with the accuracy and reliability of a Signatera™ result.

Signatera™ Indications

Signatera™ can be used for a variety of cancer types. To learn more about how, please select your role and a cancer type.

Why circulating tumor DNA (ctDNA) for molecular residual disease assay (MRD) assessment?

  • ctDNA is a powerful tool that can be measured to assess the absence or presence of MRD
  • Signatera™ is a highly sensitive and personalized MRD assay using ctDNA and is custom designed for each patient to help identify relapse earlier than standard of care tools

WEBINAR

The tipping point:

How clinically validated MRD testing is transforming patient management in colorectal cancer

60 minute webinar

Featured webinar

Watch our webinar discussing the expanding role of ctDNA for molecular residual disease (MRD) assessment in patients with colorectal cancer. Along with the recently presented data from ESMO, our experts reviewed:

  • What the recently published data reinforces in terms of patient overall (OS) and disease-free survival (DFS)
  • The importance of serial ctDNA testing to catch relapse earlier and potentially enable meaningful intervention
  • How sustained ctDNA clearance may improve disease-free survival (DFS) and patient outcomes
Watch Now

Clinical applications of ctDNA testing for MRD assessment

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Signatera™ accounts for ~95% of peer-reviewed clinical publications from commercially available MRD assays.
Signatera Logo
100+
peer-reviewed publications
~95%
All other commercially available MRD assays
<10
peer-reviewed publications

Not all MRD tests are created equal

Signatera™ is the most comprehensive MRD test available. Review our peer-reviewed publications here.

A positive Signatera™ result predicts relapse with overall positive predictive value more than 98%1-4

In clinical studies, Signatera showed high performance across multiple solid tumors

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Signatera™ is the first tumor-specific assay for truly individualized cancer care

Personalized design for every patient

  • Custom-built assay—based on the unique mutation signature of each patient’s tumor—identifies and tracks tumor mutations at the source
  • Once a personalized assay is designed, a patient’s blood can be used to accurately monitor for the presence or absence of the disease over time

How Signatera™ Works: a personalized and tumor informed approach to MRD surveillance

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Personalized, tumor-informed assay

One-time, primary tissue sample and matched normal tissue is required for whole exome sequencing and personalized test design.

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Ultrasensitive ctDNA detection

Signatera™ is designed to detect ctDNA of somatic and truncal variants to optimize sensitivity. Tumor-informed method enables filtering of CHIP mutations to decrease false positive rates.

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Optimized for longitudinal monitoring

Once the patient’s personalized test has been designed, only a blood sample is needed each subsequent time.

Recommended ordering cadence of every three months depending on tumor type and clinicians’ preference

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Order Collection Kit Now

To get started, send in your Signatera™ requisition form, sign in to the online portal or talk to your sales representative.

Sample Requirements
tumor block

Step 1

Send tumor block or slides to prepare the personalized tumor-informed assay

tube labels

Step 2

Complete information on tube labels

labeled tubes

Step 3

Place filled and labeled tubes into the absorbent sleeve and into the metallic envelope. Place the metallic envelope into the biohazard bag.

Covered by Medicare for multiple solid tumor indications

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Stage II-IV and oligometastatic colorectal cancer (CRC) in the adjuvant and recurrence monitoring settings
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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
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Muscle invasive bladder cancer (MIBC) in the adjuvant and recurrence monitoring settings
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Stage II-IV ovarian, fallopian tube, or primary peritoneal cancer in the adjuvant and recurrence monitoring settings
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For monitoring of response to immune-checkpoint inhibitor (ICI) therapy for patients with any solid tumor

Find out more about the Signatera™ test for MRD

View All Resources

Is Signatera™ right for you?

We’re here to help you find out

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References

1Reinert T, Henriksen TV, Christensen E, et al. Analysis of Plasma Cell-Free DNA by Ultradeep Sequencing in Patients With Stage I to III Colorectal Cancer. JAMA Oncology. 2019;5(8):1124-1131.

2Coombes C, Page K, Salari R, et al. Personalized Detection of Circulating Tumor DNA Antedates Breast Cancer Metastatic Recurrence. Clinical Cancer Research. 2019;25(14):4255-4263.

3Abbosh C, Birkbak N, Wilson GA, et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017,545:446–451

4Christensen E, Birkenkamp-Demtröder K, Sethi H, et al. Early Detection of Metastatic Relapse and Monitoring of Therapeutic Efficacy by Ultra-Deep Sequencing of Plasma Cell-Free DNA in Patients with Urothelial Bladder Carcinoma. 2019; 37(18):1547-1557.

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