There is no timeline yet for doing it, but FDA still intends to regulate laboratory-developed tests (LDTs) under FDA “enforcement discretion,” CDRH acting director of chemistry and toxicology devices Courtney Harper told the RAPS annual meeting audience in September. LDTs are presently marketed under the Clinical Laboratory Improvement Amendments (CLIA) without agency premarket approval. LDTs “present risks to patients,” she said. Harper defined them as tests that have been fully developed in a single laboratory for use only in that laboratory, and that have no premarket review, no independent research basis, and no requirement for clinical validity. “A company announces it is setting itself up as a lab to develop a new test as a biomarker,” she told RAPS, “and the next week we’ll see a news release that it is starting clinical tests for that soon. To us, that means that they actually don’t have enough information about the parameters of that test, if they’re still doing clinical studies on it.” That tells FDA, she said, that the labs still don’t understand the tests’ clinical performance and that the labs are marketing them for what is an investigational use without giving patients their right to informed consent. “CLIA doesn’t require any type of clinical validity,” Harper said. “It doesn’t preclude the labs from doing that type of research. All it requires is that the test be analytically valid. It does not require that you actually have knowledge of the link between the test result and the clinical diagnosis.” Due to the wide variability in lab quality, she added, “it’s very difficult for a doctor or a patient to predict what they’re getting when they order a lab-developed test.” Harper noted that FDA is actively considering a 10-month-old Genentech petition that says the bifurcated FDA/CLIA practice of regulating by business model “doesn’t make any sense.” She said that until FDA’s policy on LDTs is changed, “we’re evaluating tests by risk. We really need to make some significant public health and policy decisions.” She promised that the decisions would be made transparently and with stakeholder input. The best way for stakeholders to participate now is to comment on the Genentech petition. Harper also said that FDA regards tests that are distributed between different sites within a single corporation as not qualifying as LDTs, but as different laboratories; such tests require FDA premarket clearance or approval. She warned that companies selling LDTs have more responsibility for the potential uses of their products than many realize. Although a company may have labeled a product for research use only, it may know through agreements or conversations with customers that the test is being used for clinical purposes. So “they have a responsibility under [21 CFR 801.4] to correctly label that product. That means the company would not be able to look the other way and say ‘that’s their problem.’ A disclaimer doesn’t protect the company as much as some people think that it does.” —James G. Dickinson [Washington Wrap-Up, November]