Initial analysis of 400 patients from CIRCULATE-Japan study showcases Signatera's market-leading performance with over 95% pre-surgical detection and 92% relapse sensitivity
AUSTIN, Texas, May 20, 2021 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, today announced initial results from the CIRCULATE-Japan trial, the largest prospective molecular residual disease (MRD)-guided study to date. Part of CIRCULATE-Japan, the prospective, observational GALAXY study uses Natera’s personalized and tumor-informed circulating tumor DNA (ctDNA) test, Signatera™, to monitor MRD status in patients with stage II-IV or relapsed colorectal cancer (CRC) who are amenable to radical surgical resection.
With more than 1,500 CRC patients now enrolled in the trial, with a median follow-up time of approximately 6 months and maximum follow-up time of 13 months, the data to be presented (Abstract #3608) at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 4-8, 2021, focuses on an initial analysis of 400 patients:
- Pre-surgical ctDNA detection rates of 95% in stage II-III disease and greater than 90% overall.
- Longitudinal relapse sensitivity of 92%, which has improved to >93% in the most recent analysis. Updated results will be presented at future conferences in mid-2021.
- Exceptionally low tissue failure rate of 2.1% and plasma failure rate of 0.4%.
- Of the 4,425 genes selected for analysis across these 400 patients, only 3% were common to four or more patients, reinforcing the value of an MRD test that is personalized to each patient’s unique genetic signature.
"The exceptional quality of real-world data consistently generated by Signatera across thousands of samples shows there is considerable benefit in using a tumor-informed approach," said the study’s Principal Investigator, Dr. Takayuki Yoshino of the National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan. "We look forward to continuing our collaboration with Natera and working toward our goal of making this technology the standard of care for cancer patients worldwide."
"We’re encouraged to see such positive results from the CIRCULATE-Japan trial this early on, which validate Signatera’s market-leading sensitivity and the value of a personalized, tumor-informed approach of MRD testing," said Alexey Aleshin, M.D., Natera’s vice president of medical affairs, oncology. "Natera is deeply committed to driving insights and data about colorectal cancer which will play a critical role in helping oncologists accurately treat colorectal cancer patients, particularly when it comes to adjuvant chemotherapy. We look forward to discussing these results with the oncology community at this year’s ASCO conference."
The CIRCULATE-Japan trial, organized by the National Cancer Center (NCC) Japan, is a prospective, multi-center, randomized trial launched in January 2020 that is investigating optimal circulating tumor DNA (ctDNA)-guided treatment strategies for patients with resectable stage II-IV colorectal cancer.
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 email@example.com
SOURCE Natera, Inc.