title: Performance of a novel KRAS mutation assay for formalin-fixed paraffin embedded tissues of colorectal cancer.
abstract: 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.
authors: Department of Genome Biology, Kinki University Faculty of Medicine, Osaka-Sayama, Osaka, Japan.
authors: Kazuko
authors: K
authors: Sakai
authors: Department of Pathology, Kinki University Faculty of Medicine, Osaka-Sayama, Osaka, Japan.
authors: Azusa
authors: A
authors: Yoneshige
authors: Department of Pathology, Kinki University Faculty of Medicine, Osaka-Sayama, Osaka, Japan.
authors: Akihiko
authors: A
authors: Ito
authors: New Projects Development Division, Toray Industries, Inc., Kamakura, Kanagawa, Japan.
authors: Yoji
authors: Y
authors: Ueda
authors: New Projects Development Division, Toray Industries, Inc., Kamakura, Kanagawa, Japan.
authors: Satoshi
authors: S
authors: Kondo
authors: New Projects Development Division, Toray Industries, Inc., Kamakura, Kanagawa, Japan.
authors: Hitoshi
authors: H
authors: Nobumasa
authors: Department of Genome Biology, Kinki University Faculty of Medicine, Osaka-Sayama, Osaka, Japan.
authors: Yoshihiko
authors: Y
authors: Fujita
authors: Department of Genome Biology, Kinki University Faculty of Medicine, Osaka-Sayama, Osaka, Japan.
authors: Yosuke
authors: Y
authors: Togashi
authors: Department of Genome Biology, Kinki University Faculty of Medicine, Osaka-Sayama, Osaka, Japan.
authors: Masato
authors: M
authors: Terashima
authors: Department of Genome Biology, Kinki University Faculty of Medicine, Osaka-Sayama, Osaka, Japan.
authors: Marco A
authors: MA
authors: De Velasco
authors: Department of Genome Biology, Kinki University Faculty of Medicine, Osaka-Sayama, Osaka, Japan.
authors: Shuta
authors: S
authors: Tomida
authors: Department of Genome Biology, Kinki University Faculty of Medicine, Osaka-Sayama, Osaka, Japan.
authors: Kazuto
authors: K
authors: Nishio
keywords: 3D-Gene® KRAS mutation assay; Anti-EGFR antibody; Colorectal cancer; Companion diagnosis; KRAS mutation