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Natera Wins Preliminary Injunction Against NeoGenomics Labs, Preventing Sale of MRD Assay in US

NEW YORK – Natera said Wednesday that it has won a preliminary injunction in a patent infringement lawsuit against NeoGenomics Labs, which will severely restrict sales of NeoGenomics' Radar minimal residual disease assay.

The order from Judge Catherine Eagles of the US District Court for the Middle District of North Carolina bars the "making, using, selling, or offering for sale in the US" of the assay. The order also prohibits NeoGenomics from promoting or advertising it. NeoGenomics may continue to offer the assay for existing patients and for clinical trials, research studies, and projects already in process.

"We are pleased with the court's decision to issue a preliminary injunction," Natera said in a statement. "Any proposed workaround will need to be more than 'colorably different' from the Radar assay and not infringe our patent. We believe this presents a significant challenge for regulatory and reimbursement efforts that rely upon NeoGenomics' ongoing trials."

NeoGenomics said in a court filing that it will appeal the order to the US Court of Appeals for the Federal Circuit. ""We continue to believe in Radar's innovative and distinguished technology and plan to appeal the court's ruling and defend our technology," NeoGenomics CEO Chris Smith said in a statement. "We remain committed to bringing our highly sensitive test to market and providing cancer patients and their clinicians with options for their care."

Natera sued NeoGenomics in July, alleging infringement of two patents related to Natera's Signatera MRD assay. This case is an extension of another patent infringement lawsuit filed in 2021 against Inivata.

The injunction is the latest legal victory for Natera. Earlier this month, the US District Court for the District of Delaware issued an injunction against Invitae and ArcherDx, forcing them to stop using legacy Personalized Cancer Monitoring products. That followed a $19.4 million jury verdict in May in favor of Natera for royalties and lost profits.

"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 said. "We will continue to vigorously protect and defend our extensive portfolio of patents from unlawful infringement."