2016 may be year of action on laboratory-developed tests

During a session at the Association for Molecular Pathology’s annual meeting in November, Rep. Michael Burgess, MD (R-Tex.), said he expects the Food and Drug Administration to issue its long-awaited final guidance on laboratory-developed tests during the first quarter of 2016.

FDA officials, meanwhile, have been more circumspect in their public statements. In a recent meeting of the CDC’s Clinical Laboratory Improvement Advisory Committee, Alberto Gutierrez, PhD, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, described the agency’s potential action on LDTs in 2016 using the conditional “if.”

When the FDA released its proposed regulatory framework for LDTs in July 2014, it sparked criticism from virtually every side. What perhaps few expected was that 2015 would slip by without agency action on the matter.

The lead item in this month’s “Put It on the Board” section. Read the whole shebang.