Signatera | Natera

Custom-built
ctDNA assay
for treatment
monitoring and
MRD assessment

Custom-built
ctDNA assay
for treatment
monitoring and
MRD assessment

Custom-built
ctDNA assay
for treatment
monitoring and
MRD assessment

Custom-built
ctDNA assay
for treatment
monitoring and
MRD assessment

What is Signatera(RUO)™?

Signatera(RUO) is the first ctDNA assay custom-built for detecting molecular residual disease (MRD) and monitoring treatment. The Signatera methodology selects 16 unique, clonal, somatic variants individualized to each patient’s tumor, followed by multiplex PCR and ultra-deep sequencing for longitudinal ctDNA analysis of whole blood samples.1 The pan-tumor potential of Signatera has been demonstrated across several tumor types, including lung, colorectal, bladder, and breast.2-5

 

Natera is a leader in non-invasive genetic testing of circulating cell-free DNA (cfDNA) in the blood. Our team is powered by world-class experts in molecular biology and bioinformatics. We have built a suite of highly differentiated tests in the prenatal space despite being a late entrant in some markets (Panorama was fourth to the non-invasive prenatal testing arena, but rose to become a market leader on the strength of its SNP-based approach to identifying aneuploidies and microdeletions). To date, we have run more than a million cfDNA tests, and now we are applying our scientifically and commercially proven technology to oncology. Upon partnering with world-leading cancer research institutes, we pioneered a novel approach to detecting and monitoring ctDNA. Our research has been published in top scientific journals.

Currently, the Signatera ctDNA technology is for research use only and is not for use in diagnostic procedures.

Why is Signatera(RUO) a unique ctDNA assay?

  • Custom-built for clonality

    At diagnosis, tumor tissue and matched normal whole blood are collected from each patient for whole exome sequencing (WES). Every patient sample is used to design a custom-built, individual-specific assay targeting 16 clonal, somatic mutations known to be present in the tumor tissue (“tumor signatures”).1,3-5

    In contrast to detecting hotspot or therapeutically actionable mutations with a fixed panel approach, selecting clonal, tumor-specific variants for each patient enables deeper sequencing and a higher probability of ctDNA detection.1,6

  • High-sensitivity and specificity

    In analytical validation studies, Signatera(RUO) demonstrated the ability to detect target ctDNA from one mutant haploid genome in a background of 10,000 normal haploid genomes, with >96% sensitivity on a sample level.1 In addition, Signatera is optimized to achieve >99.5% analytical specificity on a sample level, by requiring detection of at least two mutations for a plasma sample to be considered ctDNA positive.1

  • Presence or absence of ctDNA

    A Signatera test report indicates whether a patient is ctDNA-positive or ctDNA-negative and the mean tumor molecules per ml in the sample, rather than a list of therapeutically actionable genomic alterations.

How Signatera(RUO) Works

Custom-built for each patient

ctDNA detection with high sensitivity and specificity

Contact us

References

1. Sethi H, Salari R, Navarro S, et al. Analytical validation of the Signatera™ RUO assay, a highly sensitive patient-specific multiplex PCR NGS-based noninvasive cancer recurrence detection and therapy monitoring assay. Poster presented at: American Association for Cancer Research (AACR) Annual Meeting; April 17, 2018; Chicago, IL. Abstract 4542.

2. Abbosh C, Birkbak NJ, Wilson GA, et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017;545(7655):446-451.

3. Reinert T, Henriksen TV, Rasmussen MH, et al. Serial Circulating Tumor DNA Analysis for Detection of Residual Disease, Assessment of Adjuvant Therapy Efficacy and for Early Recurrence Detection in Colorectal Cancer. Poster presented at: European Society for Medical Oncology Annual Congress; October 21, 2018; Munich, Germany. Abstract 456PD. 

4. Birkenkamp-Demtröder K, Christensen E, Sethi H, et al. Sequencing of Plasma cfDNA from Patients with Locally Advanced Bladder Cancer for Surveillance and Therapeutic Efficacy Monitoring. Poster presented at: European Society for Medical Oncology Annual Congress; October 20, 2018; Munich, Germany. Abstract 86P. 

5. Coombes RC, Armstrong A, Ahmed S. Early detection of residual breast cancer through a robust, scalable and personalized analysis of circulating tumor DNA (ctDNA) antedates overt metastatic recurrence. Poster presented at:  San Antonio Breast Cancer Symposium; December 7, 2018. San Antonio, TX. Abstract 1266.

6. Abbosh C, Birkbak NJ, Swanton C. Early stage NSCLC — challenges to implementing ctDNA-based screening and MRD detection [published online ahead of print July 3, 2018]. Nat Rev Clin Oncol. 2018;15(9):577-586. doi:10.1038/s41571-018-0058-3.

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