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SHR Neuro Cancer Cardio Lipid Metab Microb

Dijkstra, JR; Opdam, FJ; Boonyaratanakornkit, J; Schönbrunner, ER; Shahbazian, M; Edsjö, A; Hoefler, G; Jung, A; Kotsinas, A; Gorgoulis, VG; Lpez-Ros, F; de Stricker, K; Rouleau, E; Biesmans, B; van Krieken, JH.
Implementation of formalin-fixed, paraffin-embedded cell line pellets as high-quality process controls in quality assessment programs for KRAS mutation analysis.
J Mol Diagn. 2012; 14(3):187-191 Doi: 10.1016/j.jmoldx.2012.01.002 [OPEN ACCESS]
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Co-authors Med Uni Graz
Höfler Gerald
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Abstract:
In recent years, the mutational status of the KRAS oncogene has become incorporated into standard medical care as a predictive marker for therapeutic decisions related to patients with metastasized colorectal cancer. This is necessary, because these patients benefit from epidermal growth factor receptor (EGFR)-targeted therapy with increased progression-free survival only if the tumor does not carry a mutation in KRAS. Many different analytical platforms, both those commercially available and those developed in house, have been used within pathology laboratories to assess KRAS mutational status. For a testing laboratory to become accredited to perform such tests, it is essential that they perform reliability testing, but it has not previously been possible to perform this kind of testing on the complete workflow on a large scale without compromising reproducibility or the mimicry of the control sample. We assessed a novel synthetic control for formalin-fixed, paraffin-embedded (FFPE) tumor samples in a blind study conducted within nine laboratories across Europe. We show that FFPE material can, at least in part, mimic clinical samples and we demonstrate this control to be a valuable tool in the assessment of platforms used in testing for KRAS mutational status.
Find related publications in this database (using NLM MeSH Indexing)
Cell Line, Tumor -
Colorectal Neoplasms - diagnosis Colorectal Neoplasms - drug therapy Colorectal Neoplasms - genetics
DNA Mutational Analysis - standards
Fixatives -
Formaldehyde -
Genes, ras -
Humans -
Molecular Diagnostic Techniques - standards
Mutation -
Paraffin Embedding -
Proto-Oncogene Proteins - genetics
Quality Control -
Receptor, Epidermal Growth Factor - antagonists and inhibitors
Reproducibility of Results -
ras Proteins - genetics

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