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Signatera™ & Lattitude

Signatera™ + Latitude™: FDA-approved precision in MRD monitoring.

Signatera™ is a highly sensitive, tumor-informed Minimal Residual Disease (MRD) assay. By analyzing circulating tumor DNA (ctDNA) in blood, it helps detect the risk of recurrence at an early stage, monitor treatment response, and support clinical decision-making. Developed by Natera and performed in the United States, Signatera™ is an FDA-approved MRD test and is recommended by international guidelines for multiple tumor types, including colorectal, breast, and non-small cell lung cancer.

*The tumor-informed approach is based on the patient’s own tumor-specific genetic alterations, whereas the tumor-naive approach analyzes ctDNA using predefined biomarkers without establishing a patient-specific tumor profile.

Why Signatera™?

  • Assessment of treatment response during the neoadjuvant setting
  • Determination of the need for adjuvant therapy
  • Early detection of molecular recurrence
  • Monitoring of treatment response and disease management
  • Support for optimized clinical decision-making

When Is Signatera™ Used?

Signatera - Minimal Residual Disease (MRD)

How Is Signatera™ Performed?

Setup: In the initial phase, the patient’s tumor tissue is analyzed to identify tumor-specific genetic alterations and establish a personalized ctDNA profile.

Follow-up: During follow-up, blood samples are collected at defined intervals to detect ctDNA. Serial measurements help monitor molecular disease dynamics and potential molecular recurrence.

Our Portfolio

 Signatera Exome™Signatera Genome™Latitude™
Cancer TypeAll Solid Tumors (Colorectal, Breast, Lung, Bladder, etc.)All Solid Tumors (Colorectal, Breast, Lung, Bladder, etc.)Colorectal Cancer (CRC) Only
MethodologyWES-Based Signatera™ mPCR-NGSWGS-Based Signatera™ mPCR-NGSTissue-Free DNA Methylation-Based MRD Analysis
Number of Variants16 Clonal Variants64 Clonal VariantsEpigenomic Biomarker-Based Analysis
Sequencing Depth~100,000× Ultra-Deep SequencingUp to 350,000× Ultra-Deep SequencingTargeted Methylation-Based Analysis
Setup RequirementsFFPE Tumor Tissue + 1 EDTA Blood Tube + 2 Streck Blood TubesFFPE Tumor Tissue + 2 EDTA Blood Tubes + 2 Streck Blood TubesNo tumor tissue required. Setup requires 1 EDTA Blood Tube and 2 Streck Blood Tubes.
Follow-Up Sample Requirements2 Streck Blood Tubes2 Streck Blood Tubes2 Streck Blood Tubes
Turnaround Time (Setup)4–5 Weeks4 Weeks
Turnaround Time (Follow-Up)7–10 Days7–10 Days<14 Days
Key AdvantagePersonalized, Tumor-Informed MRD AnalysisUltra-High Sensitivity Personalized MRD Analysis with Strong Detection Performance Even at Very Low ctDNA LevelsRapid and Convenient MRD Assessment Without Requiring Tumor Tissue

*For patients with colorectal cancer (CRC), Latitude™ can be performed using a plasma sample only, without the need for tumor tissue.

 
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