FDA publishes proposal to increase regulatory oversight of lab-developed tests

Compared to tests built by large medtech companies and sold to labs—such as kits from Abbott, Roche, BD and others—LDTs were originally deemed a product category with comparatively lower risks. Because they’re typically manufactured in smaller volumes, the FDA initially opted not to subject them to full regulatory review; the goal was to provide smaller labs with the flexibility to diagnose rare diseases and operate on a more local scale while using techniques similar to standard tests.

However, that open door to the...