Signatera Residual Disease Tests | Clinician Information | Natera

IN THE NEWS

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

IN THE NEWS

New Publication in Nature Cancer Demonstrates Signatera’s Ability to Evaluate Tumor Response to Immunotherapy


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.


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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. 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.