Implementation of Formalin-Fixed, Paraffin-Embedded Cell Line Pellets as High-Quality Process Controls in Quality Assessment Programs for KRAS Mutation Analysis
(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)
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- author
- organization
- publishing date
- 2012
- type
- Contribution to journal
- publication status
- published
- subject
- in
- The Journal Of Molecular Diagnostics
- volume
- 14
- issue
- 3
- pages
- 187 - 191
- publisher
- Elsevier
- external identifiers
-
- wos:000303616600001
- scopus:84859602234
- pmid:22414609
- ISSN
- 1525-1578
- DOI
- 10.1016/j.jmoldx.2012.01.002
- language
- English
- LU publication?
- yes
- additional info
- The information about affiliations in this record was updated in December 2015. The record was previously connected to the following departments: Molecular Medicine (013031200)
- id
- e7f8b45c-8d3c-4007-9d65-81bfe13cb134 (old id 2826760)
- date added to LUP
- 2016-04-01 14:46:16
- date last changed
- 2022-02-19 20:47:01
@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}}, 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}}, doi = {{10.1016/j.jmoldx.2012.01.002}}, volume = {{14}}, year = {{2012}}, }