Introducing the GI Expanded Access Program for remote Signatera MRD testing | Natera

To the oncology community:

With the outbreak of COVID-19, many cancer patients and oncologists will interrupt their standard surveillance schedules, or may wish to avoid or delay chemotherapy because it can significantly weaken the immune system.

To support you and your cancer patients during this challenging time, Natera is announcing its GI Cancer Expanded Access Program, ​making Signatera MRD testing remotely available for patients with any type of GI cancer who are candidates for reducing chemotherapy or are at risk of delayed surveillance visits. Studies have shown that patients who test MRD-negative with Signatera are at significantly reduced risk of relapse, and based on clinical assessment may be eligible for treatment de-escalation and fewer scans.1-4


Through the GI Cancer Expanded Access Program, effective immediately:

  • Physicians can order Signatera testing and receive test results virtually through Natera’s online portal
  • Natera will send blood collection kits directly to patients’ homes, and blood can be drawn either by a Natera mobile phlebotomist or at a local blood draw facility
  • For a limited time under the program, all out-of-pocket costs associated with testing in any GI malignancy will automatically be managed under Natera’s Compassionate Care program, with the vast majority of patients owing zero dollars

Patient Eligibility:

  • Recurring / Standing Orders: All GI cancer patients with stage I-III & stage IV oligometastatic disease
  • Adjuvant Setting: <6 months after surgery / curative-intent treatment to inform adjuvant treatment decisions
  • Surveillance Setting: > 6 months after surgery / curative-intent treatment and in remission / NED
  • Single Time Point Orders: All GI cancer patients, any stage

To enroll, please contact your local Natera representative, or email ​ with the subject line “GI Cancer Expanded Access Program.”

1. 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. JAMA Oncol. 2019;5(8):1124–1131.
2.Coombes RC, Page K, Salari R, et al. Personalized detection of circulating tumor DNA antedates breast cancer metastatic recurrence Clin Cancer Res. 2019;;25(14):4255-426.
3. Abbosh C, Birkbak NJ, Wilson GA, et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017;545:446-451.
4. Christensen E, Birkenskamp-Demtroder 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. J Clin Oncol. 2019; 37(18):1547-1557.

These tests were developed by Natera, Inc., a laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA). These tests have not been cleared or approved by the US Food and Drug Administration (FDA). Although FDA does not currently clear or approve laboratory-developed tests in the US, certification of the laboratory is required under CLIA to ensure the quality and validity of the tests. CAP accredited, ISO 13485, and CLIA certified. © 2020 Natera, Inc. All Rights Reserved.