The increasing complexity, availability and growing use of LDTs to diagnose common but serious medical conditions such as cancer and heart disease, has sparked FDA’s renewed scrutiny and related policy positions on LDTs which have drawn the attention of Congress and raised serious concerns inside the lab industry. With advances in technology and growing demand for personalized treatment plans, increasing numbers of laboratories are developing and using custom diagnostic tests to keep pace with the changing face of disease as well as to best serve both patients and clinicians alike.
FDA’s growing involvement with LDTs leaves affected labs with trying to understand how they would be affected by the prospect for additional federal oversight. Meantime, a discussion draft for new congressional legislation, the Diagnostics Accuracy and Innovation Act (DAIA) which would affect the regulatory framework of both LDTs and in Vitro diagnostic (IVD) test kits adds yet another piece to the complex federal jigsaw puzzle for regulating LDTs. Most recently, FDA has acknowledged that comprehensive legislation ultimately is the best way to address regulation of LDTs but in the meantime, the agency is taking steps to make it easier for labs to receive premarket approval for their assays.