Author: 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.
Title: The Case for Laboratory Developed Procedures: Quality and Positive Impact on Patient Care Document date: 2017_7_16
ID: jzwwses4_24
Snippet: In the CAP KRAS-B-2015 mailing, 204 laboratories reported results from testing 3 blinded proficiency-testing specimens. The specimens contained recurring somatic mutations in KRAS exons 12 or 13 (NM_004985.3), c.35G>T (p.G12 V), and c.38G>A (p.G13D). An acceptable response was reported by over 96% of the laboratories for both mutations (197/204 for p.G12V and 195/202 for p.G13D). The vast majority of reporting laboratories utilized LDPs. 57 KRAS .....
Document: In the CAP KRAS-B-2015 mailing, 204 laboratories reported results from testing 3 blinded proficiency-testing specimens. The specimens contained recurring somatic mutations in KRAS exons 12 or 13 (NM_004985.3), c.35G>T (p.G12 V), and c.38G>A (p.G13D). An acceptable response was reported by over 96% of the laboratories for both mutations (197/204 for p.G12V and 195/202 for p.G13D). The vast majority of reporting laboratories utilized LDPs. 57 KRAS and RAS family gene mutation analysis is also critical in the management of patients with non-small-cell lung cancer (NSCLC) and other tumors, 58 for which FDA approval of kits has not occurred; LDPs or off-label use of kits is required.
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