Results from the first large, real-world study in 535 gastrointestinal (GI) cancer patients using Signatera™ MRD testing
SAN CARLOS, Calif., May 19, 2020 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, and its collaborators will present new data demonstrating the clinical validity and utility of its personalized molecular residual disease (MRD) assay, Signatera, at the 2020 American Society of Clinical Oncology (ASCO) virtual meeting taking place May 29-31, 2020.
Natera will present four abstracts — one oral and three poster presentations — showcasing Signatera’s ability to track circulating tumor DNA (ctDNA) for residual disease monitoring in colorectal cancer (CRC) and in hepatocellular carcinoma, real-world clinical experience of Signatera MRD assessment in CRC, and the identification and characterization of clonal hematopoiesis of indeterminate potential (CHIP) mutations using Signatera.
"We are looking forward to sharing new clinical data at this year’s ASCO meeting, which demonstrates our progress towards establishing Signatera as an effective tool for residual disease detection," said Alexey Aleshin, M.D., M.B.A., Natera’s Senior Medical Director for Oncology. "The data from these studies support our efforts to set a new standard in residual disease monitoring in patients with colorectal cancer, while expanding ctDNA testing applications to guide optimal treatment options for a broader range of cancer patients."
Details about the abstracts are as follows:
Abstract #4009 | Poster discussion #1
Presenter: Noelia Tarazona
Circulating tumor DNA to detect minimal residual disease, response to adjuvant therapy and to identify patients at high risk of recurrence in patients with stage I-III CRC
A study evaluating the validity of the Signatera ctDNA assay to detect MRD in CRC patients who are at high risk of recurrence, during and after adjuvant chemotherapy. Serial ctDNA analysis detected MRD up to 16.6 months before radiologic imaging.
Abstract #3531 | Poster #261
Presenter: Chih-Hung Hsu
Longitudinal and personalized detection of circulating tumor DNA (ctDNA) for monitoring efficacy of atezolizumab plus bevacizumab in patients with unresectable hepatocellular carcinoma (HCC)
A study on the use of ctDNA for monitoring the effectiveness of treatment responses to atezolizumab and bevacizumab in patients with unresectable hepatocellular carcinoma who were not previously treated with systemic therapy.
Abstract #4108 | Poster #100
Presenter: Pashtoon M. Kasi
Tumor-informed assessment of molecular residual disease and its incorporation into practice for patients with early and advanced stage colorectal cancer (CRC-MRD Consortia)
The first large, real-world study evaluating the use of Signatera to assess MRD rates and quantify ctDNA concentration in 535 patients with GI cancers, including 432 colon and 77 rectal. Detection of ctDNA was significantly associated with the stage of disease. Moreover, in patients with radiologically measurable active metastatic disease, the ctDNA detection rate was 100 percent.
Abstract #1525 | Poster #17
Presenter: Hsin-Ta Wu
Characterization of Clonal Hematopoiesis of Indeterminate Potential Mutations from Germline Whole Exome Sequencing Data
A study on Signatera’s ability to filter CHIP mutations through tumor tissue and germline sequencing to reduce the number of false-positives often caused by CHIP mutations. The study demonstrates that individuals older than 60 years with certain cancer types and therapy regimens may have a higher frequency of CHIP. These results highlight the importance of factoring in these parameters when performing ctDNA analysis for these patients.
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 has exercised enforcement discretion for laboratory-developed tests in the US, 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 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.
Investor Relations: Mike Brophy, CFO, Natera, Inc., 650-249-9090
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SOURCE Natera, Inc.