On January 6, 2020 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, reported 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 (Press release, Natera, JAN 6, 2020, View Source [SID1234552761]).
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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.
About Signatera
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.