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.

In 2009, the ASCO and the National Comprehensive Cancer Network (NCCN) recommended mutational profiling of KRAS exons 12 and13 before institution of anti-epidermal growth factor receptor (EGFR) therapy for patients with metastatic colorectal cancer; it became standard of care to assess formalin-fixed paraffin-embedded tumor tissues from patients with metastatic colon cancer for KRAS mutation status. 51, 52 It was not until 5 years later that the FDA cleared QIAGEN's therascreen KRAS test, designed to detect the presence of 7 mutations in the KRAS gene in colorectal cancer. 53 By this time, new data demonstrated that KRAS analysis alone was not enough; mutation analysis of other genes was necessary, 54, 55 and the FDA-approved assay was already inadequate for patient testing compliant with national treatment guidelines. Without LDPs, an estimated 10% of patients with non-exon 2 KRAS mutations would be overtreated with expensive anti-EGFR therapy. 56 The use of LDPs has thus persisted in clinical practice to provide patients with the most complete information to guide treatment.