The bill seeks to formalize the Clinical Laboratory Improvement Amendments as the central regulatory authority for these tests. For laboratories like ARUP, the proposal represents a shift toward transparency without the burden of device-level regulation. Jonathan Genzen, ARUP’s chief medical officer, noted that the legislation provides a constructive framework for ongoing industry discussions regarding test quality and patient safety.

The act includes provisions requiring the Centers for Medicare and Medicaid Services to maintain a public database of test performance specifications. It also mandates that laboratories report test errors resulting in serious harm and introduces a voluntary pathway for third-party validation of clinical and analytical validity. If passed, the legislation would provide a two-year implementation delay, allowing the sector time to adapt to the new reporting requirements while preserving existing device clearances.