FDA Pilot Program for Cancer Diagnostics Met with Skepticism

Scott Danzis offered his insight in a Biospace article that discussed an FDA pilot program aiming to address risks of cancer treatments that are approved without a companion diagnostic. The program is a result of the FDA’s concern over laboratory development tests (LDTs) used by healthcare providers to make treatment decisions. 

Scott pointed out that while LDTs are intended to fill in the gap, they are not necessarily regulated by the FDA in the same way as other in vitro diagnostics. “There are certainly a lot of reasons to think that the system is working quite well,” Scott said. He noted that laboratories are subject to federal and state regulation and go through a rigorous process of validation.

Scott also took a more neutral stance on the pilot program. “I’m waiting to see where it goes and how successful it is,” he said. “I think recognizing the role that laboratories play in the diagnostic industry is a positive thing for the agency and for the healthcare system more broadly.”

He added that the question of regulating LDTs extends beyond the pilot program. “If FDA wants to regulate LDTs, my view has long been that the legislation should be enacted by Congress, giving [the regulator] that clear authority and developing a system that’s suited for the unique characteristics of laboratory diagnostics.”