Natera Files Patent Infringement Suit Against NeoGenomics

AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced 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.

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.

About Natera

Natera™ is a global leader in cell-free DNA testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard of care to protect health, and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are validated by more than 150 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California. For more information, visit www.natera.com.

Forward-Looking Statements

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 developments in matters under dispute or litigation, the scope of protection we establish and maintain for, and developments or disputes concerning, our intellectual property or other proprietary rights, and our expectations 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.