Academic labs argue against FDA guidance on LDTs

A group of academic laboratories urged the White House Office of Management and Budget against the release of FDA draft guidance for regulating laboratory-developed diagnostic tests (LDTs). In a Arup Laboratories (Salt Lake City, Utah) and professor of pathology at the University of Utah School of Medicine, said imposing the FDA approval process on LDTs would cause a "crippling domino effect" on diagnostic laboratory innovation. He said the researchers support the current regulatory structure for LDTs and noted that LDTs are already subject to CLIA requirements, state laws and accreditation by "deemed authorities" such as the College of American Pathologists. The co-signers include researchers from Harvard University, University of California at San Francisco, Stanford University and the Mayo Clinic.

Currently, in vitro diagnostics are subject to both FDA medical device regulations and CLIA requirements, while LDTs are not subject to FDA review. The guidance has been tied up at OMB for at least 18 months. Earlier this month, a group of Democratic senators urged OMB to release the guidance, saying it is necessary in light of "more sophisticated, complex and high-risk LDTs coming to market" in the last decade (see BioCentury Extra, July 3). ...