ArticleMolecular diagnosis & therapy2019
Clinical Evaluation of IntelliPlex™ KRAS G12/13 Mutation Kit for Detection of KRAS Mutations in Codon 12 and 13: A Novel Multiplex Approach.
Article in Molecular diagnosis & therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
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Who cites it
4 citing papers in PubMed, 8 citations in OpenAlex.
- Validation of a rapid biomarker assay for lung cancer using the IntelliPlex panel.Scientific reports · 2025Article
- Integration of Image Pattern Recognition and Photon Sensor for Analyzing Cytokine Gene Expression Using πCode MicroDisc.Biosensors · 2024Article
- Combining the amplification refractory mutation system and high-resolution melting analysis for KRAS mutation detection in clinical samples.Analytical and bioanalytical chemistry · 2023Article
- HIV-1 viral blips are associated with repeated and increasingly high levels of cell-associated HIV-1 RNA transcriptional activity.AIDS (London, England) · 2021Article
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Authors and funding
9 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundColorectal cancer (CRC) is among the most frequently occurring cancers worldwide and its incidence is forecasted to increase. Testing for KRAS (Kirsten rat sarcoma viral oncogene homolog) mutations in colorectal tissue biopsy samples has become a crucial tool to guide therapeutic decisions for personalized treatment.
objectiveThe objective of this study was to determine the diagnostic sensitivity and specificity of the IntelliPlex™ KRAS G12/13 Mutation Kit using clinical specimens compared to Sanger sequencing as the reference method.
methodsA total of 248 formalin-fixed paraffin-embedded (FFPE) tissue samples, with CRC tumors comprising more than 10% of the whole tissue sample, were included in the study and analyzed for specific KRAS mutations in codons 12 and 13. For samples with discordant results between Sanger sequencing and the IntelliPlex™ KRAS G12/13 Mutation Kit, Pyrosequencing was utilized to resolve the KRAS mutational status.
resultsSequencing determined 153 specimens as KRAS wild-type genotype while the IntelliPlex™ KRAS G12/13 Mutation Kit confirmed 139 of the wild-type cases, resulting in a clinical specificity of 90.8% (95% confidence interval (CI) 85.12-94.91). All 95 specimens with a reported mutation in codons 12 or 13 of KRAS by sequencing were also reported as non-wild-type by the IntelliPlex™ KRAS G12/13 Mutation Kit, resulting in a clinical sensitivity to detect KRAS mutations of 100% (95% CI 96.19-100).
conclusionsThe IntelliPlex™ KRAS G12/13 Mutation Kit demonstrates suitable specificity and sensitivity for use in clinical laboratories to determine the mutational status of KRAS codons 12 and 13.
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