The U.S. District Court for the Middle District of North Carolina has ruled in favor of NeoGenomics in a significant patent infringement lawsuit, invalidating all patent claims asserted by Natera and clearing the path for broader commercialization of NeoGenomics' RaDaR ST assay.
Court Invalidates Natera's Patent Claims
The court granted NeoGenomics' motion for summary judgment, determining that all of Natera's asserted patent claims are invalid for claiming ineligible subject matter. The court stated it will dismiss Natera's claims against NeoGenomics with prejudice and enter declaratory judgment of invalidity for both of Natera's asserted patents.
"We are pleased with the Court's decision to invalidate Natera's asserted patents," said Tony Zook, CEO of NeoGenomics. "NeoGenomics is committed to providing cancer patients the most comprehensive array of diagnostic testing options to enable the highest quality of personalized care, which includes providing options for their MRD testing."
Impact on RaDaR ST Assay Commercialization
The ruling means NeoGenomics remains free to broadly commercialize the RaDaR ST assay, formerly known as RaDaR 1.1. The company has already launched RaDaR ST to biopharma customers and has submitted the assay to the Centers for Medicare & Medicaid Services' (CMS) Molecular Diagnostic Services Program (MolDX) for clinical reimbursement coverage.
Natera's Response and Broader Patent Portfolio
Natera emphasized that the invalidated patents are distinct from U.S. Patent No. 11,519,035 (the '035 patent), and the court's decision has no impact on the validity or enforceability of the '035 patent. The '035 patent previously served as the basis for a preliminary and then permanent injunction against NeoGenomics, which resulted in the removal of NeoGenomics' RaDaR v1.0 product from the market.
Natera is evaluating its options, including an appeal and further enforcement with other patents. The company maintains a broad portfolio of more than 500 issued or pending patents worldwide and remains committed to protecting its investments in innovation.
Competitive Landscape in Cancer Diagnostics
Both companies operate as major players in the oncology diagnostics space. NeoGenomics specializes in cancer genetics testing and information services, offering comprehensive oncology-focused testing menus across the cancer continuum. The company serves oncologists, pathologists, hospital systems, academic centers, and pharmaceutical firms through its network of CAP-accredited and CLIA-certified laboratories throughout the U.S. and a facility in Cambridge, United Kingdom.
Natera operates as a global leader in cell-free DNA and precision medicine, focusing on oncology, women's health, and organ health. The company's tests are supported by more than 300 peer-reviewed publications and operates ISO 13485-certified and CAP-accredited laboratories in Austin, Texas, and San Carlos, California.
