NeoGenomics Gains as Natera Ends Appeal in Cancer Test Patent Feud
FDA & Biotech

NeoGenomics Gains as Natera Ends Appeal in Cancer Test Patent Feud

Natera's voluntary withdrawal of its appeal solidifies a key legal victory for NeoGenomics, clearing the path for the Q1 2026 U.S. launch of its RaDaR cancer detection test.

NeoGenomics Inc. (NASDAQ: NEO) secured a significant legal and strategic victory on Tuesday after competitor Natera Inc. voluntarily withdrew its appeal in a high-stakes patent dispute over cancer-detection technology.

The move ends a contentious chapter in the battle for dominance in the rapidly growing market for Minimal Residual Disease (MRD) testing. The decision solidifies an August 2025 court ruling that invalidated Natera's patent claims against NeoGenomics' RaDaR assay, a highly sensitive blood test designed to detect lingering cancer cells after treatment. Shares of NeoGenomics saw a modest rise in morning trading as investors digested the news, which clears a critical hurdle for the company's commercial ambitions.

The company confirmed in a press release that Natera dropped its challenge, which was pending before the U.S. Court of Appeals for the Federal Circuit. The withdrawal leaves the district court's favorable judgment intact, providing NeoGenomics with crucial legal clarity as it prepares for a major product launch.

"We are pleased that Natera has elected to end this litigation and that the District Court’s judgment invalidating Natera’s patents will stand," said Chris Smith, CEO of NeoGenomics. "This welcome development enables our team to focus fully on ensuring a robust clinical launch of our RaDaR ST assay in the first quarter of 2026."

The Path to Commercialization

The dispute centered on technology essential for MRD testing, a revolutionary approach in oncology that can identify cancer recurrence far earlier than traditional imaging. The market is considered a multi-billion dollar opportunity, attracting intense competition among diagnostics firms.

This legal saga reached a pivotal moment in August 2025, when the U.S. District Court for the Middle District of North Carolina granted a summary judgment in favor of NeoGenomics. The court ruled that Natera's asserted patent claims were invalid, a decision that news outlets reported as a major blow to Natera's legal case. Following that ruling, Natera filed an appeal, which it has now abandoned.

With the legal overhang removed, NeoGenomics can proceed with the full U.S. clinical launch of its RaDaR ST assay early next year. The company has already introduced the test to biopharmaceutical clients for use in clinical trials and has submitted the assay for reimbursement coverage review to the Centers for Medicare & Medicaid Services (CMS), a critical step for widespread clinical adoption.

Competitive Landscape Heats Up

The resolution of the patent fight intensifies the rivalry between Florida-based NeoGenomics, with a market capitalization of approximately $1.53 billion, and Natera, a larger incumbent in the space. While this ruling favors NeoGenomics, the MRD testing market remains fiercely competitive, with several companies vying for position.

For NeoGenomics, the successful launch of RaDaR is a cornerstone of its growth strategy, aiming to capture a significant share of the personalized cancer care market. The company's focus now shifts from the courtroom to execution and market adoption. Wall Street analysts currently hold a mixed but generally positive outlook on the company, with a consensus 12-month price target of $13.44, suggesting potential upside from its current price of around $11.85. The majority of analysts rate the stock as either 'Hold' or 'Buy', reflecting both the opportunity in the MRD space and the execution risks that lie ahead.

The now-unobstructed path to market for the RaDaR test in early 2026 will be a key catalyst for NeoGenomics, with investors and healthcare providers closely watching its ability to compete and deliver on its promise of improving long-term cancer patient outcomes.