On January 9, 2020 Natera, Inc. (NASDAQ: NTRA) a global leader in cell-free DNA testing, reported a nationwide multi-center registry study called BESPOKE CRC for patients diagnosed with Stage II-III colorectal cancer (CRC) (Press release, Natera, JAN 9, 2020, View Source [SID1234552961]). The study’s objective is to measure the clinical impact of serial blood-based testing with Signatera, Natera’s personalized and tumor-informed test for molecular residual disease (MRD) assessment, earlier relapse detection, and better patient risk stratification after surgery.
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The BESPOKE CRC study will prospectively enroll 1,000 or more patients at time of surgery. Signatera testing will be performed multiple times in the first 6 months after surgery to help inform the need for adjuvant chemotherapy, and then approximately every 3 months in the surveillance setting to detect relapse early and enable more curative interventions. Patients will be followed for up to two years, to measure treatment changes and patient outcomes. The study will begin enrollment in early 2020, and it is expected to complete in 2023.
"Signatera offers a tremendous opportunity to reduce unnecessary treatment and improve long-term outcomes in patients with early-stage colorectal cancer," said Alexey Aleshin, M.D., M.B.A., Natera’s Senior Medical Director of Oncology. "We believe the BESPOKE study will help establish basic clinical protocols that will eventually become the standard of care worldwide."
In published validation studies, Signatera detected relapse in patients with Stage II-III CRC up to 16.5 months earlier (average 8.7 months earlier) than standard diagnostic tools including CT imaging and CEA.1 In May 2019, the FDA designated Signatera as a Breakthrough Device, and in August 2019, Medicare proposed to cover its use in select patients diagnosed with Stage II or Stage III colorectal cancer. There are estimated to be 145,600 new CRC diagnoses per year in the U.S., and more than one million CRC survivors.2
About Signatera
Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for clinical and research use, and in 2019 it was granted Breakthrough Device Designation by the FDA. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. This maximizes accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. Unlike a standard liquid biopsy, Signatera is not intended to match patients with any particular therapy; rather it is intended to detect and quantify how much cancer is left in the body, to detect recurrence earlier and help optimize treatment decisions. Signatera test performance has been clinically validated in multiple cancer types including colorectal, non-small cell lung, breast, and bladder cancers.
Signatera 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 U.S. Food and Drug Administration (FDA). Although FDA does not currently clear or approve laboratory-developed tests in the U.S., certification of the laboratory is required under CLIA to ensure the quality and validity of the tests.