LDTs Left Behind As Cures Initiative Moves Forward With Updated Language

Although House Energy and Commerce Chairman Fred Upton (R-MI) said he was working with FDA to modernize medical diagnostic regulatory policies, language on such policies, including for laboratory-developed tests, was once again absent from a third version of the 21st Century Cures bill unveiled Wednesday (May 13). The committee had included in its first Cures draft a placeholder on modernizing regulation of diagnostics. The lawmakers explained in an accompanying white paper: “Following FDA's proposed guidance altering the regulatory landscape for...