Draft Legislation Proposes New Category for LDTs

House of Representatives members Larry Bucshon, M.D. (R-IN) and Diana DeGette (D-CO) are looking for feedback on a discussion draft of legislation called the Diagnostic Accuracy and Innovation Act, which was introduced as an alternative to the U.S. Food and Drug Administration’s (FDA’s) framework for oversight of laboratory developed tests (LDTs). The representatives assert this draft “builds upon previous efforts to establish a modern framework for the regulation of diagnostic tests, which will benefit patients and advance precision medicine.”

The draft proposes creation of a new regulatory category for in vitro clinical tests (IVCTs) distinct from medical devices—including both finished products (such as kits and test platforms) and laboratory test protocols or LDTs.

Regulatory authority over IVCTs would be shared between the FDA and the Centers for Medicare and Medicaid Services (CMS). The FDA would oversee test “design, development, and validation of an IVCT as well as the production of an IVCT for distribution to another facility or third-party,” according to a summary of the proposed legislation. CMS, under a modernized CLIA, would have jurisdiction of “all the activities necessary to perform or ‘run’ a developed IVCT, including the preparation of reagents for use in a single CLIA facility, sample preparation, and other pre-analytical processes.” Finally, medical use of IVCT and interpretation of results would be left to the states for governance as the practice of medicine.