A new bill is being drafted by a group of lawmakers interested in creating a new federal regulatory process specifically designed for diagnostics, with Senator Orrin Hatch leading the discussions, according to a report in FDANews.
Alan Mertz, president of the American Clinical Laboratory Association, told FDANews that his group has met with Hatch on several occasions to work on the content of the bill. "Much like the 1976 Congress realizing devices didn't fit the drugs pathway, we needed a new process for diagnostics," Mertz said, noting plans to create a pathway for in vitro diagnostics and lab-developed tests.
Last summer GenomeWeb noted that some lawmakers are angling to create a Center for Advanced Diagnostics Evaluation and Research that "would be responsible for ensuring the safety and efficacy of a new category of tests called 'advanced personalized diagnostics,'" or APDxs. The draft of the bill defined APDx as a regulated product "distinct from a device" that analyzes DNA, RNA, a chromosome, a protein, or a metabolite, and that is used for diagnosing or treating disease."