Should the FDA regulate laboratory-developed diagnostic tests? —Yes.
In April 2014, the Centers for Disease Control and Prevention and the US Food and Drug Administration (FDA) published a warning in Morbidity and Mortality Weekly Report about a commercially available test for Lyme infection. The test returned the result “culture positive,” when in fact the procedure was far more complex than a routine culture. There also were “serious concerns about false-positive results caused by laboratory contamination,” leading to “the potential for misdiagnosis.”1
Sharfstein J. FDA Regulation of Laboratory-Developed Diagnostic TestsProtect the Public, Advance the Science. JAMA. 2015;313(7):667-668. doi:10.1001/jama.2014.18135