A lot of misinformation has been propagated about the FDA’s role in regulating laboratory tests. Some have advocated for FDA regulation of all lab-developed tests as “medical devices,” which could be a death knell for many of these tests and put a stranglehold on the laboratory's ability to respond to certain patient care needs. In this conversation with Dr. David Grenache, chief scientific officer for TriCore Reference Laboratories, he discusses why laboratory-developed tests play an important clinical role, how they’re currently regulated, and how to best modernize those regulations.