Signatera detects and tracks circulating tumor DNA (ctDNA) using a personalized, tumor-informed assay.
MRD Assessment | Adjuvant Treatment Guidance | Recurrence Monitoring
BESPOKE CRC study seeks to quantify the impact on treatment decisions and outcomes based on the results of SignateraTM residual disease test (MRD).
Signatera is a tumor informed ctDNA assay for tracking 16 tumor-specific mutations in the blood for MRD determination and molecular monitoring.
BESPOKE CRC will measure changes in treatment decisions and clinical outcomes based on the use of Signatera in patients with stage II and III colorectal cancer. The study will enroll at least 1,000 patients. Natera and its collaborators will collect clinical utility and outcomes data on enrolled patients for two years.
>50 sites will be selected
Multicenter clinical trials will begin enrollment in March 2020
Budget will be sponsored by Natera’s clinical trials department, with budget for Institutional
Review Board (IRB) approval, on-site coordination, data collection, and analysis.
This test was developed by Natera, Inc., a laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA). This test has 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. © 2019 Natera, Inc. All Rights Reserved.