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.

As illustrated, LDPs are an integral part of the spectrum of tests and procedures performed by clinical laboratories which fulfill a critical need for patient care, particularly in rapidly evolving areas such as testing for personalized medicine. Laboratory testing should be consistent with national/international consensus treatment guidelines, which may require development of procedures earlier or for new clinical purposes not fulfilled by FDA-approved kits. In such cases where clinical testing needs exist beyond the original FDA purpose, laboratories must be able to perform additional validation of new sample types or develop additional assays to include new mutations or analytes that are needed. As illustrated by these case examples, laboratories and professional organizations often work together to broadly compare and optimize assay performance, creating consensus standards that raise the quality of testing overall. In contrast, the current structure for FDA approval requires review of assay kits individually, or in comparison with the predicate method, rather than assessing and improving performance across the spectrum of assay options available.