FDA Considers Liquid Biopsies

In addition to laboratory developed tests and next generation sequencing, could the FDA be looking to impose standards or guidance governing use of liquid biopsies? So-called “liquid biopsies” are increasingly becoming the future for precision medicine, often allowing deep analysis of a patient’s medical condition without an invasive and uncomfortable medical procedure.

However, the regulation of liquid biopsies is also becoming an inevitability, particularly as the U.S. Food and Drug Administration (FDA) has been taking aggressive actions toward the regulation of laboratory-developed tests.

And while the FDA has been on the receiving end of criticism from the laboratory community as being heavy-handed and potentially stifling regulation, the agency did hold a joint meeting in Washington, D.C. last month with the American Association of Cancer Research to discuss the future of liquid biopsies.

The meeting was co-chaired by Gideon Blumenthal, M.D., clinical team leader, for thoracic and head/neck oncology at the FDA’s Center for Drug Evaluation and Research.

Although Blumenthal suggested that there may be room for some generalized public-private partnerships to develop liquid biopsies and protocols in the future, the daylong session was heavily weighted with discussion and debate over clinical issues. The presentations included 355 slides, most of which focused on how liquid biopsies are performed. FDA officials mostly gave the floor over to other presenters from institutions such as the Dana Farber Cancer Institute, the Memorial Sloan-Kettering Cancer Center and Johns Hopkins University.

For the most part, the FDA officials present at the session appeared to be in the exploratory phase as to how liquid biopsies and next-generation sequencing for such diagnostics are developing. The agency recently issued draft guidelines for some next-generation sequencing tests that are currently in the public comment phase.

“We’ve heard there are some concerns or doubts, some uncertainties about whether different ways of evaluating liquid biopsy results agree,” said Abraham Tzou, M.D., an FDA medical officer and a pathologist by training. “Are they telling you the same thing, are they telling you different things? Obviously the best [outcome] would be to just have clinical outcome based on liquid biopsies. … I think most people would agree that is the ultimate answer. We’ve heard about different trials or proposals that are in progress where that is primarily the design. The question of course is [what to do] in the interim.”