Study to quantify changes in post-surgical treatment and impact of early relapse detection using Signatera test
SAN CARLOS, Calif., Jan. 9, 2020 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA) a global leader in cell-free DNA testing, today announced a nationwide multi-center registry study called BESPOKE CRC for patients diagnosed with Stage II-III colorectal cancer (CRC). 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.
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
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.
Natera is a global leader in cell-free DNA testing. The mission of the company is to change the management of disease worldwide with a focus on reproductive health, oncology, and organ transplantation. Natera operates an ISO 13485-certified and CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, Calif. It offers proprietary genetic testing services to obstetricians, oncologists, transplant nephrologists, academic researchers, drug developers, and genetic laboratories through its cloud-based software platform. Natera's flagship cancer assay, Signatera, was designated by the FDA as a Breakthrough Device in 2019. For more information, visit www.natera.com, or follow Natera on LinkedIn.
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera's plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera's expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, our ability to successfully increase demand for and grow revenues for our product offerings, whether the results of clinical studies will support the use of our product offerings, our expectations of the reliability, accuracy and performance of our screening tests, or of the benefits of our screening tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera's recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.
Investor Relations: Mike Brophy, CFO, Natera, Inc., 650-249-9090
Media: Kevin Knight, 206-451-4823, firstname.lastname@example.org
- Reinert T, Henriksen T, 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
- Key Statistics for Colorectal Cancer. American Cancer Society. https://www.cancer.org/cancer/colon-rectal-cancer/about/key-statistics.html. Published 2019.
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SOURCE Natera, Inc.