WHO/BS/2017.2317 Collaborative study to evaluate the proposed WHO 1st International Reference Panel for genomic KRAS codons 12 and 13 mutations

Overview

An international collaborative study assessed the suitability of a panel of genomic DNA (gDNA) materials as the proposed World Health Organization 1st International Reference Panel for genomic KRAS codons 12 and 13 mutations, NIBSC code 16/250, for use in the standardization of KRAS oncogene codons 12 and 13 mutation-based diagnostics. The panel comprised eight freeze-dried gDNA materials of the seven most-common colorectal cancer (CRC)-associated KRAS codons 12 and 13 mutations; NM_033360.3 (KRAS) c.35G>C (p.Gly12Ala, hereafter referred to as p.G12A; NIBSC material code 16/252), c.34G>T (p.Gly12Cys, p.G12C; 16/258), c.35G>A (p.Gly12Asp, p.G12D; 16/260), c.34G>C (p.Gly12Arg, p.G12R; 16/254), c.34G>A (p.Gly12Ser, p.G12S; 16/256), c.35G>T (p.Gly12Val, p.G12V; 16/264), c.38G>A (p.Gly13Asp, p.G13D; 16/262), plus a wild-type KRAS codons 12 and 13 material (16/266). Participants evaluated the materials using their routine diagnostic methods, and against in-house controls (previously characterized patient samples and cell line-derived gDNA) or commercial materials. Where possible, results were reported quantitatively in order to assign consensus values to each of the materials. Fifty six laboratories in thirty four countries performed sixty eight testing methods on the panel, of which thirty six reported quantitative data.