Circulating Tumor DNA Testing | Signatera Advanced Cancer Detection

Signatera

Transforming the management of cancer with personalized testing

Signatera, a personalized, tumor-informed assay optimized to detect circulating tumor DNA (ctDNA) for molecular residual disease (MRD) assessment and recurrence monitoring for patients previously diagnosed with cancer.

Tests For:

Molecular Residual Disease & recurrence in solid tumors

Collection Sample:

Tissue and blood sample

Medicare

Positive draft local coverage determination


Detect residual disease early. Treat with confidence.

Signatera is the first and only patient-specific, custom-built circulating tumor DNA (ctDNA) monitoring assay to support optimal cancer treatment planning in oncology.

Here’s how it works: All cells, including cancer cells, produce cell-free DNA (cfDNA) in the body’s circulatory system. Tumors generate ctDNA, a type of cfDNA. A circulating tumor DNA test detects the presence of ctDNA, which could indicate that there are cancer cells present even after treatment.

Personalized breakthrough technology

  • Custom-built to generate results based the unique signature of a patient’s tumor
  • Tumor-informed, identifies and tracks tumor mutations at the source, enabling highly accurate monitoring of the presence or absence of disease over time
  • Achieved the Breakthrough Devices designation by the U.S. Food and Drug Administration. This recognition is given to equipment that offers innovative technology and/or significant advantages over existing alternatives.

Actionable insights

  • Use Signatera ctDNA testing after surgery to evaluate the need for adjuvant chemotherapy and avoid unnecessary treatment
  • Use Signatera to detect recurrence earlier while it may still be resectable, and reduce false positives

The Signatera Approach


Signatera has been granted Breakthrough Device Designation by the FDA.

 

Medicare issued positive draft LCD for Signatera

 


Personalized and tumor informed approach.

 

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

Positive Signatera result, without further treatment, has predicted relapse with overall PPV > 98%1-4

 

Natera: Cutting-Edge Technology for Cancer Detection

At Natera, our experience in cfDNA and ctDNA ensures accurate, precise results. Our ctDNA cancer screening provides the information you need to determine the best medical course of action when treating cancer. Talk to your doctor about how Signatera may fit into your treatment plan. To learn more about Signatera, contact us today.

 

 

 

 


"Circulating tumor DNA analysis can potentially change the postoperative management of CRC by enabling risk stratification, ACT monitoring, and early relapse detection.”

Reinert et al. JAMA Oncol. 2019;5(8):1124-1131.1


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References

  1. Reinert 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.
  2. Coombes 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.
  3. Abbosh C, Birkbak N, Wilson GA, et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017,545:446–451
  4. Christensen 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.
  5. Einstein DJ, Liang N, Malhotra M, et al. Assessment of Molecular Remission in Oligometastatic Esophageal Cancer with a Personalized Circulating Tumor DNA Assay. JCO-Precision Oncology. 2020;4:239-243.