Data will be used to support submission to CMS for reimbursement, expanding Signatera's coverage beyond early-stage colorectal cancer
AUSTIN, Texas, July 22, 2021 /PRNewswire/ — Natera,Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, today announced the publication of a new peer-reviewed study validating its personalized and tumor-informed molecular residual disease (MRD) assay, Signatera, for use in oligometastatic colorectal cancer (oligo mCRC). Signatera has now been featured in 14 peer-reviewed publications.
A new study published in JCO Precision Oncology presents an analysis from the prospective PREDATOR clinical trial, following 112 patients with oligo mCRC who underwent surgical resection with curative intent. MRD status was assessed using Signatera after surgery and during follow-up following a pre-specified analysis plan. The study validates 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 to prospectively assess overall survival in MRD-positive and negative patients, setting an important new standard for test performance and evidence quality.
Key findings from the study include:
- At the first time point post-surgery, Signatera identified MRD positivity in 54% of patients (61/112), demonstrating sensitivity to progression of 72% (59/82) and PPV of 97% (59/61).
- Serial testing improved Signatera sensitivity to 91%, among patients who did not receive adjuvant treatment, with 100% overall survival among those who remained serially MRD-negative.
- 96% of patients who were MRD-negative at the single time point after surgery were still alive at the end of clinical follow-up (up to 54 months), relative to 52% of MRD-positive patients. MRD status was the only significant prognostic factor in a multivariate analysis.
"There remains a high unmet need for reliable biomarkers of prognosis for oligometastatic colorectal cancer," said Fotios Loupakis, M.D., Ph.D., department of oncology, Istituto Oncologico Veneto, IRCCS, and lead author of the paper. "Through this study, we are able to show that a personalized ctDNA test is a sensitive prognostic biomarker that can potentially be used to guide treatment decisions for patients with oligometastatic colorectal cancer."
Clinical guidelines are currently vague on post-surgical management for patients with oligo mCRC, as approximately 1 in 5 metastatic CRC patients achieve cure with surgery alone,1 and the evidence is unclear on which patients may benefit from adjuvant chemotherapy. Oligo mCRC patients are also monitored closely for recurrence, as early detection can enable another chance at a potential cure.
"We are very encouraged by the performance of Signatera in the setting of oligometastatic colorectal cancer," said Alexey Aleshin, M.D., Natera’s vice president of medical affairs, oncology, and co-author of the paper. "We see a significant opportunity to improve the management of patients with oligometastatic disease, who make up 20 to 30%2-4 of all metastatic colorectal cancer patients, and we look forward to working closely with Medicare to secure coverage for this indication, as an extension of the current coverage in early-stage 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 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 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 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 be repeated in later 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 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
Media: Kate Stabrawa, Communications, Natera, Inc., 720-318-4080 email@example.com
- 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 randomised 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-based 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.