On June 23rd, the Verifying Accurate, Leading-edge IVCT Development (VALID) Act was reintroduced in the House and Senate by Reps. Larry Bucshon (R-IN) and Diana DeGette (D-CO), and Richard Burr (R-NC) and Michael Bennet (D-CO), respectively.
This bill, like its previous version, would create a new FDA review process for laboratory developed tests (LDTs) as well as in vitro diagnostics and place them both under a new regulatory category of "in vitro clinical tests." By subjecting IVDs and LDTs to the same regulatory process, VALID would significantly increase administrative requirements and costs on laboratories. The result would inevitably limit patient access to these vital tests.
LDTs are already well-regulated regulated by the Centers for Medicare and Medicaid Services (CMS) through the Clinical Laboratory Improvement Amendments (CLIA). AACC has long been opposed to extending duplicative FDA oversight to LDTs and instead favors modernizing CLIA regulations to address concerns about LDTs.
In March 2021, AACC endorsed the Verified Innovative Testing in American Laboratories (VITAL) Act, which would codify the existing regulatory structure under CLIA. The association will continue to work with all stakeholders to identify and advance effective, separate, regulatory pathways for LDTs and IVDs.