The FDA has announced that it will not release final guidance on laboratory developed tests (LDTs), and instead will work with Congress and other stakeholders to determine how LDTs should be regulated, the American Clinical Laboratory Association (ACLA) said.
The decision “is a victory for diagnostic innovation and most importantly, patients,” Alan Mertz, the ACLA’s president, said. “We appreciate the FDA’s acknowledgement that stakeholder input and the ongoing bipartisan work carried out in the House and Senate is the appropriate process to advance comprehensive statutory reform of the LDT regulatory framework.”
Mertz said the ACLA has consistently maintained that LDTs are not medical devices and cannot be regulated as such.
Currently, most tests that are developed and used within a single facility are regulated by the Centers for Medicare & Medicaid Services, under the Clinical Laboratory Improvement Amendments. They can include in vitro diagnostics, blood tests, and assays evaluating whether a patient will respond to a specific drug.