Austin, Texas, July 22, 2021 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a pioneer and world leader in cell-free DNA testing, today announced the publication of a new peer-reviewed study validating the personalized and tumor-informed residual molecular disease (MRD) test, Signatera, for use in oligometastatic colorectal cancer (oligo mCRC). Signatera is now featured in 14 peer-reviewed publications.
a new study published in JCO Precision Oncology presents an analysis of the prospective PREDATOR clinical trial, after 112 patients with oligo mCRC who underwent surgical resection with curative intent. MRD status was assessed with Signatera after surgery and during follow-up according to a pre-specified analysis plan. The study confirms Signatera’s high sensitivity and specificity in identifying the patients most likely to relapse without additional treatment. It is also Natera’s first major publication in CRC prospectively assessing the overall survival of MRD positive and negative patients, setting an important new standard for test performance and quality of evidence.
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The main findings of the study include:
- At the first time point after surgery, Signatera identified MRD positivity in 54% of patients (61/112) demonstrating a susceptibility to progression of 72% (59/82) and PPV of 97% (59/61).
- Serial testing improved the sensitivity of Signatera by up to 91% in patients who did not receive adjuvant treatment, with an overall survival of 100% in those who remained serially MRD negative.
- 96% of patients who were MRD-negative at any time point after surgery were alive at the end of clinical follow-up (up to 54 months), compared to 52% of MRD-positive patients. MRD status was the only significant prognostic factor in a multivariate analysis.
“There remains a great unmet need for reliable biomarkers for the prognosis of oligometastatic colorectal cancer,” said Photos Loupakis, MD, Ph.D., division of oncology, Istituto Oncologico Veneto, IRCCS, and lead author of the paper. “Through this study, we can demonstrate that a personalized ctDNA test is a sensitive prognostic biomarker that could potentially be used to guide treatment decisions for patients with oligometastatic colorectal cancer.”
Clinical guidelines are currently vague on postoperative treatment for patients with oligo-mCRC, as approximately 1 in 5 patients with metastatic CRC achieve healing with surgery alone,1
and the evidence is unclear about which patients may benefit from adjuvant chemotherapy. Oligo mCRC patients are also closely monitored for recurrence, as early detection allows a new chance for a potential cure.
“We are very encouraged by Signatera’s performance in the setting of oligometastatic colorectal cancer,” said Alexey Aleshin, MD, Natera’s vice president of medical affairs, oncology and co-author of the paper. “We see an important opportunity to treat patients with oligometastatic disease, who account for 20 to 30%2-4 of all patients with metastatic colorectal cancer, and we look forward to working closely with Medicare to secure coverage in this indication, as an extension of current coverage in early-stage colorectal cancer.”
Signatera is a customized circulating tumor DNA test (ctDNA) for monitoring the treatment and assessment of residual molecular disease (MRD) in patients previously diagnosed with cancer. The test is available for both clinical and research use and has received three Breakthrough Device Designations from the FDA for multiple cancer types and indications. The Signatera test is personalized and tumor-informed, providing each individual with a custom blood test tailored to the unique signature of clonal mutations found in that person’s tumor. This maximizes Signatera’s 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 aims 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. Signatera was developed and the performance characteristics determined by Natera, the CLIA certified laboratory conducting the test. The test is not approved or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified and CLIA certified.
Natera is a pioneer and world leader in cell-free DNA testing based on a simple blood sample. The company’s mission is to change the treatment 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 provides proprietary genetic testing services to inform obstetricians, transplant physicians, oncologists and cancer researchers, including biopharmaceutical companies, and genetic labs through its cloud-based software platform. For more information visit natera.com. Follow Natera on LinkedIn.
Any statements other than statements of historical fact in this press release are forward-looking statements and are not representations that Natera’s plans, estimates or expectations will be realized. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update any forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, our ability to successfully meet the demand for and increase revenue for our product offerings, whether the results of clinical or other studies are replicated in subsequent studies or 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 for patients, providers and payers. Additional risks and uncertainties are discussed in more detail in “Risk Factors” in Natera’s recent filings on Forms 10-K and 10-Q and in other filings Natera makes from time to time with the SEC. These documents are available at: www.natera.com/investors and www.sec.gov.
Investor Relations: Mike Brophy, CFO, Natera, Inc., 650-249-9090
Media: Kate Stabrawa, Communications, Natera, Inc., 720-318-4080 [email protected]
- Tomlinson JS, Jarnagin WR, DeMatteo RP, et al. Actual 10-year survival after resection of colorectal liver metastases defines cure. J Clin Oncol. 2007;25(29):4575-4580.
- 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 randomized 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 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.