1 oral and 3 poster presentations demonstrate effectiveness of Signatera™ in stage IV oligometastatic colorectal cancer (CRC), stage I-III CRC, and esophageal adenocarcinomas
SAN CARLOS, Calif., Sept. 18, 2020 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, today announced it will present new data on its personalized molecular residual disease (MRD) test, Signatera, at the 2020 European Society for Medical Oncology (ESMO) virtual meeting taking place September 19-21, 2020.
Natera will present four abstracts — one oral and three poster presentations — which highlight applications for detecting MRD levels and tracking tumor clonal evolution in CRC and in esophageal adenocarcinoma.
"When CRC patients present with multiple lesions, recurrence monitoring may be complicated by spatial heterogeneity between the primary tumor and the metastases," said Andrés Cervantes, M.D., Ph.D., President-Elect of ESMO and co-author of the tumor evolution study. "Our study leverages a tumor-informed ctDNA technology that can evaluate and account for this heterogeneity."
"We’re delighted to share new data at this year’s ESMO meeting, which shows the broad potential of our tumor-informed approach to MRD assessment," said Alexey Aleshin, M.D., M.B.A., Senior Medical Director of Oncology at Natera. "These studies demonstrate that Signatera provides clinically actionable information that can improve the management of patients with multiple different solid cancers."
Details about the abstracts are as follows:
Abstract #405MO | Mini Oral Presentation
Presenter: Fotios Loupakis, M.D., Ph.D.
Personalized circulating tumor DNA assay for the detection of minimal residual disease in CRC patients undergoing resections of metastases.
This study evaluated the prognostic value of MRD testing after surgical resection of metastases. MRD positivity correlated with inferior progression-free survival and was the most significant biomarker for prognosis in patients with oligometastatic CRC.
Abstract #420P | Poster Presentation
Presenter: Tenna V. Henriksen, M.S.
MRD detection and tracking tumor evolution using ctDNA in stage I-III colorectal cancer patients
A prospective, multicenter cohort study that analyzed the genetic heterogeneity between primary tumor, metastases, and synchronous tumors in patients with stage I-III CRC using Signatera. While primary and metastatic tumors showed at least 50 percent phylogenetic similarity, synchronous CRC tumors were observed to be genetically unrelated and required individual Signatera assays to be designed for reliable ctDNA detection.
Abstract #1491P | Poster Presentation
Presenter: Emma Ococks, M.S.
Bespoke circulating tumor DNA assay for the detection of minimal residual disease in esophageal adenocarcinoma patients
A pilot study that evaluated the ability of tumor-informed ctDNA testing to assess MRD status in patients with esophageal adenocarcinoma, a low-shedding tumor type. Postoperative assessment of MRD detected clinical relapse with a median lead time of 335 days and with 100 percent sensitivity.
Abstract #520TiP | Poster Presentation
Presenter: Pashtoon Kasi, M.D., M.S.
A multicenter study to evaluate the impact of circulating tumor DNA guided therapy (BESPOKE) in patients with Stage II and III colorectal cancer
A trial-in-progress poster presentation, describing the first real-world, prospective, multicenter study (BESPOKE) utilizing a tumor-informed ctDNA test to assess MRD status in 1000 patients with stage II and III CRC over the course of two years. The primary endpoint of this study is to examine the impact of Signatera on adjuvant treatment decisions and to determine the rates of CRC recurrence while asymptomatic.
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 to 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 has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.
Natera is a pioneer and global leader in cell-free DNA testing. The mission of the company is to change the management of disease worldwide with a focus on women’s health, oncology, and organ health. Natera operates an ISO 13485-certified and CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, California. 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, whether the results of clinical or other studies will support the use of our product offerings, our ability to successfully increase demand for and grow revenues for our product offerings, our expectations regarding the reliability, accuracy and performance of our screening tests, or regarding the benefits of our screening tests and product offerings to patients, providers and payers, or coverage and reimbursement determinations from third-party 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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