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 >85 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.

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

Clinical applications of ctDNA testing for MRD assessment

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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

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

Personalized, tumor-informed assay

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

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.

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

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

Step 1

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

Step 2

Complete information on tube labels

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

Stage II-IV and oligometastatic colorectal cancer (CRC) in the adjuvant and recurrence monitoring settings

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

Muscle invasive bladder cancer (MIBC) in the adjuvant and recurrence monitoring settings

Stage II-IV ovarian, fallopian tube, or primary peritoneal cancer in the adjuvant and recurrence monitoring settings

For monitoring of response to immune-checkpoint inhibitor (ICI) therapy for patients with any solid tumor

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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