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 treatment monitoring and minimal residual disease (MRD) assessment. The Signatera methodology identifies 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 (RUO) 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”).1,3,4

    Targeting more individual-specific mutations than a generic panel approach may lead to a higher probability of ctDNA detection and enables deeper sequencing1,6

  • High-sensitivity and specificity

    In analytical validation studies, Signatera (RUO) demonstrated the ability to detect one mutant ctDNA molecule from two 10 ml tubes of blood (~8-9 ml of plasma) 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 variable allele frequency (VAF) levels of mutant alleles 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. Personalized circulating tumor DNA analysis to monitor colorectal cancer. Poster presented at: American Association for Cancer Research Annual Meeting; April 17, 2018; Chicago, IL. Abstract 1590.

4. Birkenkamp-Demtröder K, Christensen E, Sharma S, et al. Sequencing of plasma cfDNA from patients with locally advanced bladder cancer for surveillance and therapeutic efficacy monitoring. Poster presented at: American Association for Cancer Research Annual Meeting; April 17, 2018; Chicago, IL. Abstract 3653.

5. Natera, data on file

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.

Back to Top