ASCO presentations come on the heels of new Signatera™ data in ovarian cancer presented at AACR
AUSTIN, Texas, May 3, 2021 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, today announced it will present 4 posters at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 4-8, 2021. These presentations will highlight the unique applications of the Signatera molecular residual disease (MRD) test in colorectal cancer and multiple myeloma.
This comes on top of two new studies that were recently presented at the American Association for Cancer Research (AACR) annual meeting. One study reported superior performance by Signatera compared to standard of care CA-125, in detection of cancer recurrence with 100% sensitivity and specificity on average 10 months ahead of radiological findings, among 25 patients with early-stage ovarian cancer who were tested serially after surgical resection.1 The other study at AACR reported a stronger clinical benefit when using Natera’s method for quantifying ctDNA levels using an absolute measure of mean tumor molecules per milliliter of plasma (MTM/mL); instead of the more common variant allele frequency (VAF) used by other ctDNA tests, which can be confounded by significant changes in the background cell-free DNA caused by biological factors unrelated to the cancer.2
"We look forward to presenting these groundbreaking new results at this year’s ASCO conference, in particular the CIRCULATE-Japan data that should set a new benchmark for MRD assay performance in the context of the largest prospective multicenter study of its kind," said Alexey Aleshin, M.D., M.B.A., vice president of medical affairs, oncology, at Natera. "We are also excited to be sharing new evidence on the clinical validity of Signatera in a number of new cancer types, further demonstrating our commitment to advancing the field of MRD testing across solid tumors."
The ASCO abstract titles are as follows:
Abstract # 3540 | Serial circulating tumor DNA analysis for assessment of recurrence risk, benefit of adjuvant therapy, growth rate and early relapse detection in patients with stage III colorectal cancer
Abstract # 8029 | Personalized, ctDNA analysis to detect minimal residual disease and identify patients at high risk of relapse with multiple myeloma
Abstract # 3608 | Minimal Residual Disease by Circulating Tumor DNA Analysis for Colorectal Cancer Patients Receiving Radical Surgery: An Initial Report form CIRCULATE-Japan
Abstract # 4103 | Tumor-informed assessment of circulating tumor DNA and its incorporation into practice for patients with hepatobiliary cancers
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 both clinical and research use, and has been granted three Breakthrough Device Designations by the FDA for multiple cancer types and indications. 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. Signatera is intended to detect and quantify how much cancer is left in the body, to detect recurrence earlier and to help optimize treatment decisions.
The 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 from a simple blood draw. 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 ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and 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, 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 tests, or of the benefits of our 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., 510-826-2350
Media: Kate Stabrawa, Communications, Natera, Inc., 720-318-4080 firstname.lastname@example.org
- Chapman JS, et al. Circulating tumor DNA predicts disease recurrence in ovarian cancer patients [abstract]. American Association for Cancer Research. Virtual meeting. Poster presentation 552. April 9-14, 2021. https://www.abstractsonline.com/pp8/#!/9325/presentation/1649
- Tin A, et al. Correlation of variant allele frequency and mean tumor molecules with tumor burden in patients with solid tumors [abstract]. American Association for Cancer Research. Virtual meeting. Poster presentation 569. April 9-14, 2021. https://www.abstractsonline.com/pp8/#!/9325/presentation/1666
SOURCE Natera, Inc.