Heated legal battles continue in cell-free DNA testing market

Lawsuit Social

Clinical genetic testing manufacturer Natera announced another victory in its fight to stop other companies from capitalizing on cell-free DNA (cfDNA) testing that appears to infringe on its patents.

In late December 2023, the U.S. District Court for the Middle District of North Carolina granted Natera a preliminary injunction against NeoGenomics over selling its RaDaR assay molecular residual disease (MRD) test in the U.S. NeoGenomics, which operates cancer genetic testing laboratories in several states, had announced the commercial availability of the RaDaR assay in March 2023 after the test had been available for clinical research studies and pharmaceutical collaborations. NeoGenomics planned to appeal the decision.

Natera said in its statement that the NeoGenomics injunction strengthens Natera's position in the MRD market.

More genetic testing patent disputes are pending. Trial in a separate patent infringement case is expected to start January 22, 2024, in the U.S. District Court of Delaware. In this lawsuit, Natera has accused CareDx of infringing on two patents that cover DNA amplification technology in Natera’s Panorama cfDNA test.

CareDx, which offers specialty testing for organ transplant health and services, and Natera have been entangled in lawsuits over the past few years. In 2022, CareDx brought a case against Natera for false advertising of the Prospera transplant test that likened Prospera to CareDx's Allosure Kidney test. This case resulted in a jury award to CareDx of $45 million, but the ruling was later amended to not uphold the monetary damages. CareDx eventually got an injunction prohibiting Natera from falsely advertising and overstating the performance of the Prospera test.

Meanwhile, Invitae and Natera patent disputes continue. In May 2023, Invitae was hit with a $19.4 million jury award against its ArcherDx unit, and, later, a permanent injunction ordering ArcherDx to stop using products containing material patented by Natera. Invitae's President and CEO Ken Knight said during an Invitae Q3 corporate earnings call that the company's enhanced personalized cancer monitoring (PCM) assay chemistry addressed the issues arising from the Natera litigation and provides an "even more differentiated solution."

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