Order enjoins NeoGenomics from making, using, selling or promoting its RaDaR molecular residual disease (MRD) assay in the United States with limited exceptions

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced that the federal District Court for the Middle District of North Carolina has issued a preliminary injunction, effective immediately, enjoining the RaDaR assay from NeoGenomics Labs, Inc. (“NeoGenomics”).

The injunction bars NeoGenomics from “making, using, selling, or offering for sale in the United States… the accused RaDaR assay,” or “any assay or product not more than colorably different” from the NeoGenomics RaDaR assay. In addition, the order prohibits NeoGenomics from “promoting, advertising, marketing, servicing, distributing or supplying” RaDaR to induce infringement by others. NeoGenomics may continue to offer RaDaR for existing patients and for clinical trials, studies or projects already in process.

Natera stated, “We are pleased with the Court’s decision to issue a preliminary injunction. Any proposed workaround will need to be more than ‘colorably different’ from the RaDaR assay and not infringe our ‘035 patent. We believe this presents a significant challenge for regulatory and reimbursement efforts that rely upon NeoGenomics’ ongoing trials.”

Today’s news follows an order in a separate matter earlier this month by the Delaware Federal District Court, which issued a permanent injunction against Invitae Corporation (“Invitae”) and its Personalized Cancer Monitoring (PCM) product. In issuing that decision, the Court barred Invitae from using its infringing PCM product and any product or service not more than colorably different from PCM, with some limited exceptions.

"With a second injunction granted within two months, Natera’s IP position in the tumor-informed, personalized molecular monitoring and MRD market has been further validated,” the company continued. “We will continue to vigorously protect and defend our extensive portfolio of patents from unlawful infringement.”

For additional information, view the Court’s preliminary injunction order and supporting memorandum.

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 180 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, expected regulatory and reimbursement outcomes, 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.

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