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Detect residual disease before it spreads

Introducing the first ctDNA surveillance tool – the sooner you know, the sooner you can act

Detect residual disease before it spreads

Introducing the first ctDNA surveillance tool – the sooner you know, the sooner you can act

Detect residual disease before it spreads

Introducing the first ctDNA surveillance tool – the sooner you know, the sooner you can act

Detect residual disease before it spreads

Introducing the first ctDNA surveillance tool – the sooner you know, the sooner you can act

Know sooner. Decide with confidence.

Uncertainty in oncology decision-making is an ongoing challenge
Detecting molecular levels of residual disease and defining disease progression is a challenge with conventional tests such as imaging tools and serum tumor biomarkers.1-4 Even after careful evaluation of test results, clinicopathologic factors, and discussion of potential risks and benefits with patients, the choice of treatment is not always clear.

Signatera is the first and only circulating tumor DNA (ctDNA) surveillance tool that detects molecular residual disease (MRD) for greater clinical confidence when assessing disease recurrence or treatment response in solid tumors.

When your next treatment step is unclear, MRD status can be an important factor to consider in the clinical decision-making process.

Signatera is the only custom ctDNA test that provides early knowledge of disease recurrence with a >99.5% clinical test specificity5-8 

  • Custom-designed and manufactured for each patient
  • Tumor-informed – Detects ctDNA by tracking 16, tumor-specific, clonal variants based on whole exome sequencing (WES) of tumor tissue and matched normal blood
  • Detects residual disease, and monitors progression or treatment response – Provides important information In the adjuvant or metastatic settings, enabling faster incorporation of the next best course of action 

Implement a longitudinal surveillance strategy with Signatera to monitor MRD and treatment response throughout the continuum of care.

 
 

Implement a longitudinal surveillance strategy with Signatera to monitor MRD and treatment response throughout the continuum of care.

 
 

Implement a longitudinal surveillance strategy with Signatera to monitor MRD and treatment response throughout the continuum of care.

 
 

Implement a longitudinal surveillance strategy with Signatera to monitor MRD and treatment response throughout the continuum of care.

 
 

Ultra-sensitive ctDNA detection

Signatera's unique assay design is optimized to detect low levels of ctDNA with high sensitivity and specificity

  • Reliably detects target ctDNA at variant allele frequency (VAF) of below 0.1%, versus static panels9-11
  • At VAF of 0.01%, sample level sensitivity for MRD detection by tracking 16 ctDNA variants is >99%9
    • Detects variant allele frequencies down to 0.01%—one mutant haploid genome in a background of 10,000 normal haploid genomes9

Low detection limit allows for MRD detection with longer lead time

  • In clinical studies with Signatera, 53% of total cancer relapse cases had ctDNA first detected at VAF of between 0.01% and 0.1%5, 7, 8
    • Average lead times of ctDNA detection prior to clinical or radiological recurrence was 26% (77 days) longer in patients with 0.01%-0.1% VAF

Signatera is optimized to detect extremely low quantities of ctDNA and to determine presence or absence of molecular residual disease (MRD).5-8 

 

Signatera Billing and Customer Care: 650.489.9050
Hours of operation: Monday - Friday 7am-7pm CST and Saturday 8am-5pm CST
Email: signateracc@natera.com

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References

  1. Corcoran RB, Chabner BA. Application of cell-free DNA analysis to cancer treatment. N Engl J Med. 2018;379(18):1754-1765.
  2. Kramer J, Price ER, Jochelson MS, et al. Breast MR imaging for the assessment of residual disease following initial surgery for breast cancer with positive margins. Eur Radiol. 2017;27(11):4812-4818.
  3. Borcoman E, Nandikolla A, Long G, Goel S, Le Tourneau C. Patterns of response and progression to immunotherapy. Am Soc Clin Oncol Educ Book. 2018;38:169-178.
  4. Perkins GL, Slater ED, Sanders GK, Prichard JG. Serum tumor markers. Am Fam Physician. 2003;68(6):1075-1082.
  5. 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. In: Proceedings from the AACR Annual Meeting; April 14-18, 2018; Chicago, IL. Abstract 4542.
  6. Reinert T, Henriksen TV, Christensen E, et al. Analysis of plasma cell-free DNA by ultradeep sequencing in patients with stages I to III colorectal cancer [published online ahead of print May 9, 2019]. JAMA Oncol. 2019. doi:10.1001/jamaoncol.2019.0528.
  7. 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 [published online ahead of print May 6, 2019]. J Clin Oncol. 2019. doi: 10.1200/JCO.18.02052.
  8. Abbosh C, Birkbak NJ, Wilson GA, et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017;545(7655):446-451.
  9. Coombes RC, Page K, Salari R, et al. Personalized detection of circulating tumor DNA antedates breast cancer metastatic recurrence [published online ahead of print April 16, 2019]. Clin Cancer Res. 2019. doi: 10.1158/1078-0432.CCR-18-3663.
  10. Lanman RB, Mortimer SA, Zill OA, et al. Analytical and clinical validation of a digital sequencing panel for quantitative, highly accurate evaluation of cell-free circulating tumor DNA. PLoS One. 2015;10(10):e0140712. doi:10.1371/journal.pone.0140712.
  11. Plagnol V, Woodhouse S, Howarth K, et al. Analytical validation of a next generation sequencing liquid biopsy assay for high sensitivity broad molecular profiling. PLoS One. 2018;13(3):e0193802. doi:10.1371/journal.pone.0193802.
  12. Stetson D, Ahmed A, Xu X, et al. Orthogonal comparison of four plasma NGS tests with tumor suggests technical factors are a major source of assay discordance. JCO Precis Oncol. 2019;3. doi:10.1200/PO.18.00191.
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