NeoGenomics announced that Natera has voluntarily withdrawn its appeal in the North Carolina District Court case that had challenged the company’s RaDaR ST molecular residual disease (MRD) assay. The withdrawal leaves in place the August 2025 ruling that invalidated Natera’s asserted patent claims and was entered with prejudice, effectively ending the cross‑appeal and clearing a major legal hurdle for NeoGenomics’ U.S. launch.
The court’s decision was a pivotal moment for NeoGenomics, which had been waiting for a clear path to commercialize its RaDaR ST assay. The assay is scheduled to launch in the first quarter of 2026 and is positioned to capture a share of the estimated $30 billion MRD market. By eliminating the litigation risk, NeoGenomics can now allocate resources to scaling production, securing reimbursement, and expanding its MRD portfolio, which the company identifies as a core growth engine.
Financially, NeoGenomics reported Q3 2025 revenue of $188 million, up 12% year‑over‑year, driven by a 15% increase in clinical test volumes. The company posted a net loss of $27 million for the quarter, a decline from the prior year, while adjusted EBITDA fell 9% to $12.2 million. Management reaffirmed its full‑year 2025 guidance, indicating confidence that the legal win will translate into stronger commercial traction for RaDaR ST.
CEO Tony Zook emphasized that the withdrawal “allows us to focus our full attention on executing a robust clinical launch of RaDaR ST in the first quarter of next year.” He added that the company remains committed to expanding its diagnostic offerings for cancer patients, noting that the legal victory strengthens its competitive position against rivals such as Roche, Labcorp, and Guardant Health.
The market has historically reacted positively to NeoGenomics’ legal milestones. The August 2025 ruling that invalidated Natera’s patents triggered a 21.78% surge in NeoGenomics’ stock and a 36.12% rally over four days, underscoring investor confidence in the company’s ability to commercialize its MRD products. While specific market reaction to the December 15 withdrawal is not documented, the precedent suggests a favorable outlook for NeoGenomics’ launch plans.
NeoGenomics’ strategic focus on MRD testing, combined with the removal of a key regulatory barrier, positions the company to accelerate its growth trajectory in a rapidly expanding market. The legal win also mitigates the risk of future patent disputes, providing a more stable foundation for the company’s long‑term commercialization strategy.
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