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

AUSTIN, Texas / Dec 27, 2023 / Business Wire / 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

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