Signatera Advanced Cancer Detection | Natera

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.

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

Actionable insights

  • Use Signatera 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

 

 

 

 


"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


Questions about Signatera? Contact us.



References

  1. Reinert T, Henriksen TV, Christensen E, et al. JAMA Oncol. 2019. doi:10.1001/jamaoncol.2019.0528.
  2. Coombes RC, Page K, Salari R, et al. Clin Cancer Res. 2019. doi: 10.1158/1078-0432.CCR-18-3663.
  3. Abbosh C, Birkbak NJ, Wilson GA, et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017;545:446-451.
  4. Christensen E, Birkenskamp-Demtroder K, Sethi H, et al. J Clin Oncol. 2019. doi: 10.1200/JCO.18.02052.