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 KRAS gene encodes a GTPase critical in signal transduction that is known to be mutated in a wide range of tumor types. 45 A landmark study presented at the American Society of Clinical Oncology (ASCO) meeting in 2007 demonstrated that patients with metastatic colorectal cancer harboring a mutated KRAS failed to respond to targeted therapy with cetuximab. 46, 47 At the time, there were no clinical tests for KRAS mutations available. Molecular pathology laboratories worked quickly to fill this need, to define the best analytic approaches, and to ensure that test results done in one laboratory matched those done in another. [48] [49] [50] Within a few months, laboratories were able to offer fully validated KRAS assays that worked reliably and were safe for patient care. Under CLIA, the validation data collected by these laboratories were subject to ongoing peer review, and laboratories participate in ongoing PT to demonstrate consistent assay quality.