Advanced

Implementation of Formalin-Fixed, Paraffin-Embedded Cell Line Pellets as High-Quality Process Controls in Quality Assessment Programs for KRAS Mutation Analysis

Dijkstra, Jeroen R.; Opdam, Frank J. M.; Boonyaratanakornkit, Jerry; Schoenbrunner, E. Ralf; Shahbazian, Mona; Edsjö, Anders LU ; Hoefler, Gerald; Jung, Andreas; Kotsinas, Athanassios and Gorgoulis, Vassilis G., et al. (2012) In The Journal Of Molecular Diagnostics 14(3). p.187-191
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... (More)
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. (J Mal Diagn 2012; 14:187-191; DOI: 10.1016/j.jmoldx.2012.01.002). (Less)
Please use this url to cite or link to this publication:
author
, et al. (More)
(Less)
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
The Journal Of Molecular Diagnostics
volume
14
issue
3
pages
187 - 191
publisher
Elsevier Inc.
external identifiers
  • wos:000303616600001
  • scopus:84859602234
ISSN
1525-1578
DOI
10.1016/j.jmoldx.2012.01.002
language
English
LU publication?
yes
id
e7f8b45c-8d3c-4007-9d65-81bfe13cb134 (old id 2826760)
date added to LUP
2012-07-03 10:26:05
date last changed
2017-10-08 04:05:22
@article{e7f8b45c-8d3c-4007-9d65-81bfe13cb134,
  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. (J Mal Diagn 2012; 14:187-191; DOI: 10.1016/j.jmoldx.2012.01.002).},
  author       = {Dijkstra, Jeroen R. and Opdam, Frank J. M. and Boonyaratanakornkit, Jerry and Schoenbrunner, E. Ralf and Shahbazian, Mona and Edsjö, Anders and Hoefler, Gerald and Jung, Andreas and Kotsinas, Athanassios and Gorgoulis, Vassilis G. and Lopez-Rios, Fernando and de Stricker, Karin and Rouleau, Etienne and Biesmans, Bart and van Krieken, J. Han J. M.},
  issn         = {1525-1578},
  language     = {eng},
  number       = {3},
  pages        = {187--191},
  publisher    = {Elsevier Inc.},
  series       = {The Journal Of Molecular Diagnostics},
  title        = {Implementation of Formalin-Fixed, Paraffin-Embedded Cell Line Pellets as High-Quality Process Controls in Quality Assessment Programs for KRAS Mutation Analysis},
  url          = {http://dx.doi.org/10.1016/j.jmoldx.2012.01.002},
  volume       = {14},
  year         = {2012},
}