In a remarkable move, the Food and Drug Administration recently indicated that it plans to take new steps to regulate laboratory-developed tests (“LDTs”). FDA Commissioner Margaret Hamburg made the significant announcement during a speech on June 2, 2013, at an annual meeting of the American Society of Clinical Oncology. Historically, FDA has exercised enforcement discretion when regulating LDTs and generally exempted them from regulatory requirements because LDTs have often consisted of low-risk diagnostics or tests for rare diseases with a physician evaluating the test results in the laboratory. Consequently, LDTs oftentimes have been marketed without premarket review by FDA.

In recent years, LDTs have become increasingly complex, with physicians relying on LDTs for clinical decision-making in personalized medicine and cancer screening. Because many LDTs are currently marketed without premarket review, Commissioner Hamburg announced that FDA is developing a risk-based framework to regulate LDTs and evaluate their safety and efficacy. In doing so, according to Commissioner Hamburg, FDA plans to “provide medical professionals with a critical baseline for confidence in the tests they order for their patients.”

Though Commissioner Hamburg did not elaborate on when FDA plans to carry out this new enforcement policy with respect to LDTs, Commissioner Hamburg’s comments are expected to have a forceful impact on the diagnostics industry, where many historically have not been compelled to undergo the rigors of premarket review for LDT products. It is possible that FDA will pursue a stratified approach and begin its enforcement efforts by targeting the more complex tests relied upon for clinical decision-making. Renewed enforcement efforts by FDA would also likely raise questions as to whether new fields, such as DNA sequencing, would be treated as LDTs. In light of these remarkable implications, the diagnostic industry will be closely watching for more detailed guidance by FDA on its planned changes to the current scheme of LDT regulation.