LDT Regulation Appears to Be Stalled

Whatever happened to the lab-developed test (LDT) regulation being put together by the Food and Drug Administration (FDA)? According to the top official in the FDA’s Office of In Vitro Diagnostics and Radiological Health, the guidance may have stalled. Speaking at the 2013 American Association for Clinical Chemistry (AACC) annual meeting in Houston this summer, Alberto Gutierrez, Ph.D., said intense lobbying by industry groups has stalled progress on the guidance and changed the tone of FDA’s previously open discussion with stakeholders, according to an AACC report from the meeting. “At one time I thought the agency could put a proposal on the table, and we could have a discussion,” said Gutierrez. “Three years later, I can tell you only that I can’t tell you that it’s not going to happen; I can’t tell you that it’s going to happen—it’s out of my hands. I have no idea whether the agency will be able to put together a proposal for this or not.” Gutierrez still believes LDT regulation is needed and offered recent examples of problems, including the ongoing use of the BD SurePath test for human papillomavirus screening, which is approved only for Pap testing. Times Calls for Release of Guidance Gutierrez’s comments at AACC came not long after the New York Times editorial board called on the FDA to release the LDT draft guidelines as quickly as possible, charging that “an alarming number of diagnostic medical tests have never been tested for safety and accuracy.” According to the July 7 editorial, if a diagnostic test is made by a traditional device manufacturer, the FDA reviews its safety and effectiveness before approving it for marketing. However, if a test is developed by a clinical laboratory for use at its own facilities, it can be sold without a premarket review. “That bifurcated approach made sense in years past when a medical center might develop a diagnostic test for its own doctors and patients,” said the Times. “But the landscape has changed with the advent of more sophisticated tests and the rapid expansion of commercial laboratory companies.” The Times editorial fails to recognize that LDTs are already regulated under the Clinical Laboratory Improvement Amendments. Takeaway: Despite pressure both for and against the LDT draft guidance, little appears to be happening with the regulation.