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 >170 peer-reviewed publications and with now >300K 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.

Select your role:

Select 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

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%^2-9

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

Signatera™ Genome sequences deeper on the most critical variants to provide a more clinically meaningful MRD signal

Ultra-deep sequencing (up to 350,000x coverage for each selected variant) DRFS by ctDNA Status¹
Highly curated selection of 64 clonal variants for optimized balance of ultrasensitivity and high specificity²
Proprietary variant selection and calling algorithms for bespoke MRD monitoring

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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

Personalized, tumor-informed assay

One-time, primary tissue sample and matched normal sample is required for whole exome or whole genome 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.

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 I-III non-small cell lung cancer (NSCLC) in the surveillance setting

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

¹Nakamura Y, et al. ctDNA-based molecular residual disease and survival in resectable colorectal cancer. Nature Medicine. 2024.

²Shaw et al. Serial Postoperative Circulating Tumor DNA Assessment Has Strong Prognostic Value During Long-Term Follow-Up in Patients With Breast Cancer. JCO Precis Oncol. 2024.

³Martin T, et al. Early real-world experience monitoring circulating tumor DNA in resected early-stage non-small cell lung cancer. J Thorac Cardiovasc Surg. 2024.

⁴Christensen E, 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. J Clin Oncol. 2019.

⁵Huffman B, et al. Analysis of Circulating Tumor DNA to Predict Risk of Recurrence in Patients with Esophageal and Gastric Cancers. JCO Precision Oncology. 2022.

⁶Ansstas G, et al. Longitudinal ctDNA monitoring for post-surgical disease surveillance in patients with stage I-IIIb melanoma. Clinical Cancer Research. 2026.

⁷Hou JY, et al. Circulating tumor DNA monitoring for early recurrence detection in epithelial ovarian cancer. Gynecologic Oncology. 2022.

⁸Hanna et al. Personalized ctDNA for Monitoring Disease Status in Head and Neck Squamous Cell Carcinoma. Clin Cancer Res. 2024.

⁹Galanina et al. Real-World Evaluation of ctDNA for Risk Stratification Across the Spectrum of Both Aggressive and Indolent Lymphomas. Presented at ASH Annual Meeting. December 6-9, 2025.

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