LDT thoughts offer nuance, and advice
Two roads diverged in a regulated wood—and here comes Joe Lennerz, MD, PhD, happy not to be traveling both. As Dr. Lennerz considers this spring’s final rule from the FDA that regulates laboratory-developed tests as medical devices, he’s also kept an eye on the range of responses to the agency’s actions. One path is, broadly speaking, reactive; the other, proactive. He sees himself as a traveler on the latter road. This is perhaps unsurprising; he readily acknowledges he has professional sympathies with oversight agencies. He’s on the federal advisory panel for the Centers for Medicare and Medicaid Services. He also helped launch a group, the self-evidently named Pathology Innovation Collaborative Community, that includes FDA participation. “So I’ve been involved—let’s call it active collaborating—in this with the agency [FDA] for a number of years, at least since 2018,” he says. His motive is simple, his stride confident: “You can wait for regulation—guidance, final rules—to drop. Or you can become proactively involved. I am not reactionary. I always look to talk to the agency rather than criticize them.”