Studies show Signatera's accuracy in identifying 100% of stage IV oligometastatic CRC patients in a pre-surgical setting, and the clinical utility of Signatera in optimizing post-surgical treatment decisions for patients with Stage II-III CRC and stage IV oligometastatic CRC
SAN CARLOS, Calif., July 7, 2020 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, along with its collaborators, presented two distinct studies (one oral and one poster presentation) at the recent 2020 virtual ESMO World Congress on Gastrointestinal Cancer that took place July 1-4, 2020.
The studies highlight: a) the clinical validity of Signatera™, a personalized and tumor-informed circulating tumor DNA (ctDNA) assay for identifying molecular residual disease (MRD) in patients with oligometastatic CRC; and b) a prospective trial, already in progress, that will measure the clinical outcomes of MRD-guided treatment in stage II-III CRC patients.
These presentations build upon a fast-growing set of evidence that Signatera MRD testing is valid and useful for guiding post-surgical treatment decisions in colorectal cancer (escalation or de-escalation of therapy), including for late-stage oligometastatic patients where surgical resection may lead to cure.
"Now that Signatera is being used in prospective interventional trials, we’re seeing confirmation that it can help inform treatment decisions after oligometastatic resection in the 20 percent to 30 percent of patients with metastatic CRC,"1-3 said Alexey Aleshin, M.D., M.B.A., Natera’s Senior Medical Director for Oncology. "This clinical data suggest ctDNA testing is a highly accurate tool in guiding treatment and supports the advancement of our efforts with Signatera to improve cancer management."
Details about the abstracts are as follows:
Assigned ID: SO-34 | Oral Presentation
Presenter: Stacey A. Cohen, M.D.
Clinical Experience of a Personalized and Tumor-Informed Circulating Tumor DNA Assay for Minimal Residual Disease Detection in Oligometastatic Colorectal Cancer Patients
This study is a sub-analysis of the first large, real-world study using personalized MRD in 535 unique patients with Stage I-IV CRC, and is one of the first studies to evaluate ctDNA detection rates in late-stage oligometastatic CRC. The study found that ctDNA detection was significantly associated with stage of disease, demonstrating a detection rate of 100 percent in patients with active metastatic disease in a pre-surgical setting.
Assigned ID: P-120 | Poster Presentation
Presenter: Hiroki Yukami, M.D.
Prospective observational study monitoring circulating tumor DNA in resectable colorectal cancer patients undergoing radical surgery: GALAXY study in CIRCULATE-Japan (Trial in Progress)
The poster presentation highlighted the GALAXY study design, a prospective, observational study, which is part of the CIRCULATE-Japan trial, organized by the National Cancer Center (NCC) Japan. The CIRCULATE-Japan trial is a multicenter, randomized trial that will investigate optimal ctDNA-guided treatment strategies for patients with Stage II-III CRC, particularly adjuvant chemotherapy decisions based on MRD status.
Signatera is a custom-built ctDNA test for treatment monitoring and MRD assessment in patients previously diagnosed with cancer. The test is available for clinical and research use, and it was granted Breakthrough Device Designation by the FDA in 2019. 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 to help optimize treatment decisions. Signatera’s test performance has been clinically validated in multiple cancer types including colorectal, non-small cell lung, breast, and bladder cancers. Medicare has proposed insurance coverage for the use of Signatera in patients with Stage II or III colorectal cancer, and it is expected to finalize that coverage decision in mid-2020. Signatera has been developed and its performance characteristics determined by the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). Although FDA is exercising enforcement discretion of premarket review and other FDA legal requirements for 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 certified, and CLIA certified. © 2020 Natera, Inc. All Rights Reserved.
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 inform obstetricians, transplant physicians, oncologists, and cancer researchers, including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. For more information, visit natera.com. 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 or other 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.
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- Primrose J, Falk S, Finch-Jones M, et al. Systemic chemotherapy with or without cetuximab in patients with resectable colorectal liver metastasis: the New EPOC randomised controlled trial. Lancet Onco. 2014;15(6):601-611.
- Hackl C, Neumann P, Gerken M, et al. Treatment of colorectal liver metastases in Germany: a ten-year population-based analysis of 5772 cases of primary colorectal adenocarcinoma. BMC Cancer. 2014;14:810.
- Vatandoust S, Price TJ, Karapetis CS. Colorectal cancer: Metastases to a single organ. World J Gastroenterol. 2015;21(41):11767–11776.
SOURCE Natera, Inc.