On July 31, 2023 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, reported that it has filed a lawsuit in the North Carolina Federal District Court against NeoGenomics Labs, Inc. ("NeoGenomics") for infringement of Natera’s U.S. Patent Nos. 11,519,035 and 11,530,454 by NeoGenomics’ RaDaR molecular residual disease assay (Press release, NeoGenomics Laboratories, JUL 31, 2023, View Source [SID1234633560]).
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This lawsuit builds on Natera’s current patent infringement lawsuit in the United States District Court for the District of Delaware related to RaDaR tests sold by Inivata, an affiliate of NeoGenomics. The company’s filing of this new suit follows a recent jury verdict in favor of Natera in the U.S. District Court for the District of Delaware in the patent infringement suit it filed against ArcherDX/Invitae Corp.
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 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. Signatera is intended to detect and quantify cancer left in the body, at levels down to a single tumor molecule in a tube of blood, to identify recurrence earlier and to help optimize treatment decisions.