Rep. Dunn Introduces Bill to Enhance Innovation in Clinical Labs

WASHINGTON, D.C.-Congressman Neal Dunn, M.D. today introduced the Enhancing Clinical Laboratory Innovation and Access Act (Enhancing CLIA Act) of 2026 to update the regulation of diagnostic testing services under the Clinical Laboratory Improvement Amendments (CLIA), to further innovation.

CLIA, created in 1988 to provide guidelines to ensure safe development of diagnostic tests, is overseen by the Centers for Medicare & Medicaid Services (CMS) and remains the framework for regulating laboratory testing services. The Enhancing CLIA Act of 2026 provides a necessary update to reflect advancements in science and patient care.

Clinical laboratories play a critical role in diagnosing disease, guiding treatment decisions, advancing precision medicine, and supporting public health. By updating CLIA to reflect modern laboratory science and codifying clear lines of regulatory authority, the Enhancing CLIA Act provides regulatory certainty, strengthens accountability, and ensures continued innovation in diagnostic testing.

"As a physician, I know firsthand that timely and accurate diagnostic testing is essential to patient care. The Enhancing CLIA Act will strengthen innovation, increase transparency, and modernize regulation of laboratory developed testing services," said Congressman Dunn. "This legislation restores confidence in testing services while avoiding duplicative and burdensome requirements that limit patient access and slow scientific progress. We can ensure necessary oversight of the CLIA program without undermining the laboratories that deliver cutting-edge diagnostics to patients across the country."

The Enhancing CLIA Act would:

• Direct CMS to establish a transparent and publicly accessible database with key information regarding laboratory developed testing services (LDTs), including summaries of performance specifications and validation information
• Reaffirm that LDTs are professional services regulated by CMS under CLIA
• Clarify that LDTs include innovative analyses of digital laboratory information, such as genomic data derived from previously-sequenced patient samples
• Leverage existing review and oversight mechanisms to allow laboratories to voluntarily obtain confirmation from a recognized third party that an LDT is analytically and clinically valid
• Establish centralized error reporting and bolster CMS oversight authority if credible information indicates an LDT lacks analytical or clinical validity
  

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