Medical Tests
Personalized MRD 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.
Clinical Applications
Signatera™ can be used for a variety of cancer types.
Signatera™ is custom-built to your unique set of tumor mutations to predict colorectal cancer recurrence. Because it is highly sensitive it can detect very small traces of tumor in the body so the oncologist can know earlier if cancer is present and make more informed decisions regarding the treatment.
Signatera™ is covered by Medicare (U.S.A.) for Stage II-IV and oligometastatic colorectal cancer (CRC) in the adjuvant and recurrence monitoring settings.
Personalized molecular residual disease (MRD) testing in bladder cancer.
Signatera™ is covered by Medicare U.S.A. for muscle invasive bladder cancer (MIBC) in the adjuvant and recurrence monitoring settings.
Signatera™ can be used to help better manage your patient’s lymphoma with a more personalized approach to their care including assessing MRD status after completion of initial therapy to help predict relapse and identifying patients who are MRD-positive to inform additional treatments.
Understanding MRD
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.
Across the Cancer Journey
Clinical Evidence
Signatera™ is the most comprehensive MRD test available. Review our peer-reviewed publications here.
Validated Performance
In clinical studies, Signatera showed high performance across multiple solid tumors.
Truly Individualized
How It Works
One-time, primary tissue sample and matched normal sample is required for whole exome sequencing and personalized test design.
Once the patient’s personalized test has been designed, only a blood sample is needed each subsequent time.
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.
Coverage
Questions, Answered
Signatera™ is a personalized, tumor-informed assay optimized to detect circulating tumor DNA (ctDNA) for molecular residual disease (MRD) assessment, treatment response monitoring, and early recurrence monitoring.
Unlike other ctDNA assays, Signatera™ is designed to accurately detect MRD (i.e., not designed for early cancer screening nor for identifying actionable mutations for therapy selection). Instead, Signatera™ is customized for each patient’s unique tumor signature to optimize sensitivity and specificity for accurate MRD assessment.
By only tracking tumor-specific variants, sensitivity is maximized with a low limit of detection (LOD) of 0.01% variant allele frequency (VAF). Also, Signatera™ filters out clonal hematopoiesis of indeterminate potential (CHIP) mutations to greatly reduce false-positive results.
Signatera™ reports the presence or absence of circulating tumor DNA (ctDNA) and ctDNA quantity in terms of mean tumor molecules per mL (MTM/mL) to allow for assessment of tumor burden over time.
A positive test result indicates the presence of molecular residual disease (MRD). Serial sampling can be used to track whether disease burden is increasing or decreasing in response to treatment.
A negative result indicates that molecular residual disease (MRD) was not detected. Serial sampling can be used to track whether disease burden remains undetectable or increases to catch relapse early.
For initial testing, tumor tissue will need to be provided as a formalin-fixed paraffin-embedded (FFPE) block or on slides. The first blood draw will require one 6 ml EDTA tube and two 10 mL Streck tubes. All subsequent draws will only require two 10 mL Streck tubes.
Initial test design takes 5-6 weeks after receipt of tumor and blood samples. Subsequent blood draws have a turnaround time of 15 days.
Advanced Medilinks Pvt Ltd is an authorized distributor of Natera’s Signatera™ in India. The content has not been reviewed by nor endorsed by Natera, Inc. Advanced Medilinks Pvt Ltd is solely responsible for maintaining content according to Natera partnership guidelines as well as all legal and regulatory requirements in India. CAP accredited, ISO 13485 and CLIA certified. © 2026 Natera, Inc. All Rights Reserved.
Transforming the management of cancer with personalized testing Signatera™ is a highly sensitive and personalized molecular residual disease assay (MRD) using circulating tumor DNA (ctDNA), custom designed for...
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