[ Title ]
- Performance of a novel KRAS mutation assay for formalin-fixed paraffin embedded tissues of colorectal cancer
[ Journal ]
- Springerplus
[ Author ]
- K. Y. Sakai, A.Ito, A.Ueda, Y.Kondo, S.Nobumasa, H.Fujita, Y.Togashi, Y.Terashima, M.De Velasco, M. A.Tomida, S.Nishio, K.
[ Abstract ]
- We compared the performance of the 3D-Gene(R) mutation assay (3D-Gene(R) KRAS mutation assay kit) with the Scorpion-ARMS (therascreen(R) KRAS RGQ PCR Kit) and Luminex (MEBGEN KRAS kit) assays for the detection of KRAS mutations in formalin-fixed, paraffin-embedded tissue samples from 150 patients diagnosed with colorectal cancer. DNA was extracted from the paraffin-embedded tissue samples with or without macrodissection under hematoxylin and eosin staining and the KRAS mutation status was independently determined using these assays. Discordant results were re-analyzed by Sanger sequencing. Mutation detection analysis was successfully performed in all 150 specimens using the 3D-Gene(R) mutation assay without an invalid case. The concordance rate between the 3D-Gene(R) mutation assay and Scorpion-ARMS or Luminex was 98.7% (148/150). KRAS mutations were detected at a frequency of 35.3% (53/150) in colorectal cancer specimens. Three discrepant cases were found between the three assays. Overall, our results demonstrate a high concordance rate of between the 3D-Gene(R) mutation assay and the two existing in-vitro diagnostics kits. All three assays proved to be validated methods for detecting clinically significant KRAS mutations in paraffin-embedded tissue samples.