U.S. Congressman Neal Dunn introduced the Enhancing CLIA Act of 2026, aiming to update oversight provisions for laboratory-developed tests after a 2025 court decision that treated LDTs as medical services outside direct FDA device regulation. The proposal would shift central oversight to CMS under CLIA. Key elements include establishing an LDT database for performance and validation data, enabling voluntary third-party review for analytical and clinical validity, and creating centralized error reporting mechanisms. The bill also defines LDTs as professional services, covering not just wet-lab assays but also analyses of lab information and data. For diagnostics companies and clinical labs, the bill represents a legislative effort to reassert transparency and validation expectations while preserving access to lab-developed innovation.