Performance of a novel KRAS mutation assay for formalin-fixed paraffin embedded tissues of colorectal cancer

Kazuko Sakai, Azusa Yoneshige, Akihiko Ito, Yoji Ueda, Satoshi Kondo, Hitoshi Nobumasa, Yoshihiko Fujita, Yosuke Togashi, Masato Terashima, Marco A. De Velasco, Shuta Tomida, Kazuto Nishio

Research output: Contribution to journalArticlepeer-review

10 Citations (Scopus)


We compared the performance of the 3D-Gene® mutation assay (3D-Gene® KRAS mutation assay kit) with the Scorpion-ARMS (therascreen® 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® mutation assay without an invalid case. The concordance rate between the 3D-Gene® 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® 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.

Original languageEnglish
Article number7
Pages (from-to)1-6
Number of pages6
Issue number1
Publication statusPublished - Dec 1 2015
Externally publishedYes


  • 3D-Gene® KRAS mutation assay
  • Anti-EGFR antibody
  • Colorectal cancer
  • Companion diagnosis
  • KRAS mutation

ASJC Scopus subject areas

  • General


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