SAN CARLOS, Calif., Jan. 6, 2020 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced it has exceeded its 2019 goal of $40-$50 million in cumulative total contract value (TCV) and has expanded its personalized ctDNA minimal residual disease (MRD) and monitoring intellectual property portfolio with 8 newly allowed or issued patents in 2019.
Natera's achievement of $55 million in TCV represents significant growth over its 2018 TCV of $9.1 million. Natera has now signed over 50 agreements, covering more than 15 different cancer indications. Use cases for testing include upfront selection of MRD-positive patients, treatment on molecular recurrence, and as a surrogate endpoint for therapy effectiveness.
"We are very encouraged by the speed of adoption by pharma since launching the CLIA version of our Signatera test in May 2019. We look forward to building upon this success in 2020," said John Fesko, SVP of Business Development at Natera.
Additionally, Natera achieved key intellectual property milestones with 8 new oncology patents issued or allowed by the U.S. Patent and Trademark Office in 2019, expanding Natera's personalized ctDNA MRD and monitoring IP estate to over 60 total assets. Natera now has an extensive portfolio of IP with over 200 assets, nearly half of which are issued or allowed.
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 clinical and research use, and in 2019 it was designated by the FDA as a Breakthrough Device. 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 tissue. 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 help optimize treatment decisions. Signatera test performance has been clinically validated in multiple cancer types including colorectal, non-small cell lung, breast, bladder and other cancers.
Signatera was developed by Natera, Inc. a laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA). This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). Although FDA does not currently clear or approve laboratory-developed tests in the U.S., 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 physicians who care for pregnant women, 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, our expectations regarding the reliability, accuracy and performance of our screening tests, or regarding the benefits of our screening tests and product offerings to patients, providers and payers, or our ability to obtain favorable coverage and reimbursement determinations from third-party 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: Allison Rogan, [email protected]
SOURCE Natera, Inc.