ARTICLE | Regulation

New Diagnostics Pathway

Details emerge of Sen. Hatch plan for new regulatory pathway for diagnostics

December 6, 2010 8:00 AM UTC

FDA and members of Congress are putting the finishing touches on different proposals to create a new regulatory pathway for diagnostics, making it almost certain that major changes will be unveiled in 2011. The question is which approach will prevail - and whether either approach solves the problem of value-based reimbursement.

Top FDA officials and lawmakers have concluded that the current oversight system for diagnostics, which imposes premarket review requirements for in vitro diagnostics (IVDs) but not for the vast majority of laboratory-developed tests (LDTs), is not sufficient to protect the public or to support the development of innovative tests that are at the heart of hopes for widespread adoption of personalized medicine...