Legal and regulatory landscapes continue to shape oncology diagnostic markets. A recent court ruling invalidated two patents asserted by Natera over NeoGenomics’ Radar ST minimal residual disease assay, allowing wider commercialization without infringement liability. Despite the dismissal, related patent disputes persist concerning other technologies. Concurrently, FDA complete response letters (CRLs) impacted several radiopharmaceutical agents, including Telix Pharmaceuticals’ renal cancer imaging agent Zircaix, citing manufacturing comparability deficiencies requiring further data. Outlook Therapeutics also faced FDA rejection regarding its bevacizumab biosimilar for wet age-related macular degeneration after not meeting primary efficacy endpoints, triggering significant share price drops and industry reassessment. These actions underscore the evolving regulatory scrutiny and IP battles in precision oncology diagnostics.