The Case for Laboratory Developed Procedures: Quality and Positive Impact on Patient Care

Kaul, Karen L.; Sabatini, Linda M.; Tsongalis, Gregory J.; Caliendo, Angela M.; Olsen, Randall J.; Ashwood, Edward R.; Bale, Sherri; Benirschke, Robert; Carlow, Dean; Funke, Birgit H.; Grody, Wayne W.; Hayden, Randall T.; Hegde, Madhuri; Lyon, Elaine; Murata, Kazunori; Pessin, Melissa; Press, Richard D.; Thomson, Richard B.

The FDA review process is well suited for diagnostic assays that are commercially marketed as kits designed to operate across a spectrum of laboratory settings, in laboratories with a range of expertise. Currently, FDA approval or clearance requires prospective clinical trial data and a lengthy review process, and thus, FDA approval takes considerable effort and time. The investment needed for this process impacts the types of tests, and also sample types, that are submitted for approval, as manufacturers must recover their investment afterward. Additionally, FDA approval for an in vitro diagnostic (IVD) specifies the sample type, clinical purpose, and other aspects of performance of the assay. When a new clinical need for the IVD arises, the need to use a new sample type arises, or any needed modification that arises in response to the ongoing and sometimes rapid advancements seen in medicine, incorporation of these improvements renders the test an LDP, with the validation needs of an LDP under CLIA. Laboratories can be caught between the regulations and the needs to best serve their patients.