Signatera Clinicians | Natera

In the news

The first and only, custom-built, tumor-informed assay for early MRD detection

IN THE NEWS

Awarded positive Medicare draft coverage for serial use in Stage II & III CRC


About Signatera and Circulating Tumor DNA (ctDNA)


Signatera residual disease test (MRD)

  • Personalized tests, custom-built for each patient

  • Tumor-informed analysis for highest accuracy


How Signatera MRD Works



Medicare proposed coverage for certain types of Stage II-III colorectal cancer

Surveillance Program for Stage II - III colorectal cancer patients

Use Signatera alongside CEA to detect recurrence earlier while it may still be resectable, and reduce false positives.

 

MRD Program for Stage II - III colon cancer, Stage IIA rectal cancer

Use Signatera after surgery to evaluate the need for adjuvant chemotherapy and avoid unnecessary treatment.

 

 


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

The Only Significant Risk Factor in Stage II-III Colorectal Cancer 5-8

In multivariate analysis, Signatera status was the only significant predictor of long-term patient outcomes, after adjusting for all known clinicopathological risk factors including disease stage and lymph node status1

 

 

Signatera Test Performance in Stage II-III Colorectal Cancer

  ctDNA
High Risk
ctDNA
Reduced Risk
Actionable results: Stage II-III Colorectal Consider directed imaging (PET/MRI) to locate the disease while potentially resectable Continue monitoring with reassurance
Test interpretation >97% of patients will relapse 12-14% patients may relapse. Patients who remain negative 2 years post treatment have risk reduced to 3%.

When to use Signatera?9


 

 


Why should you use Signatera?



What we need from your lab

Matched tumor/normal sample collection


 

 


Plasma Sample Collection



Signatera Reports

Easy-to-interpret longitudinal report for MRD assessment and monitoring

Download Sample Report


Signatera Residual Disease BESPOKE Study

Natera sponsors prospective, multicenter BESPOKE Studies, which examine the clinical utility of the Signatera™ ctDNA test for monitoring recurrence and guiding treatment decisions in patients with solid tumors.

 

Want to collaborate with Natera in our current Colorectal Cancer BESPOKE Study?

Learn More: BESPOKE Study 


Questions about Signatera? Contact us.



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. 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.
  6. Sinicrope FA, Foster NR, Thibodeau SN, et al. DNA Mismatch Repair Status and Colon Cancer Recurrence and Survival in Clinical Trials of 5-Fluorouracil-Based Adjuvant Therapy. J Natl Cancer Inst. 2011;103(11):863–875.
  7. Aoyama, Oba K, Honda M, et al. Impact of postoperative complications on the colorectal cancer survival and recurrence: analyses of pooled individual patients’ data from three large phase III randomized trials. Cancer Med. 2017;6(7):1573–1580.
  8. Yothers G, O’Connell MJ, Lopatin M, et al. Validation of the 12-gene colon cancer recurrence score in NSABP C-07 as a predictor of recurrence in patients with stage II and III colon cancer treated with fluorouracil and leucovorin (FU/LV) and FU/LV plus oxaliplatin. J Clin Oncol. 2013;31(36):4512-4519.
  9. National Comprehensive Cancer Network. Colon Cancer V. Plymouth Meeting, PA: National Comprehensive Cancer Network. 2019.