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Han van Krieken

The Quality assurance program on KRAS testing of the ESP: ongoing progress.

Handout (pdf 39 p)

Handout (pdf 10 p)

Abstract:

The number of molecular tests we as pathologists perform for treatment decisions increases rapidly. These new tests need a different approach to validation and external quality assessment (EQA) and it is therefore that the ESP had decided to set up a European program for EQA for RAS mutational analysis in colorectal cancer. This program was set up with emphasis on the close interaction of pathologists and molecular biologists. More than 350 laboratories participated so far and those with a good result can be found via the ESP website. Next to RAS mutation testing for patients with colorectal cancer, ALK and EGFR testing has become the topic of external quality assurance.
We found that in each round about 10-15% laboratories have not a good enough result, but that upon 2nd participation all performed well. We also encountered new issues in the transition from KRAS to RAS testing: incomplete uptake of the full program, more problems with the rarer mutations. Furthermore, there is an unresolved sensitivity issue. Next generation sequencing is rapidly replacing standard methods and the number of genes that need to be evaluated in a certain tumor is increasing which is a new challenge for EQA. EQA itself needs standardization as well and therefore a guideline for molecular EQA programs was published recently.
It is the vision of the ESP that molecular pathology is now an integrated part of pathology and thus it is important high quality can be delivered. Where possible the ESP wishes to support this vision. Much more information can be found on the website.

References
1: van Krieken JH, et al. Guideline on the requirements of external quality assessment programs in molecular pathology. Virchows Arch. 2013;462:27-37.
2:  Dequeker E, et al. Mutation analysis of KRAS prior to targeted therapy in colorectal cancer: development and evaluation of quality by a European external quality assessment scheme. Virchows Arch. 2011;459:155-60.

3:  Bellon E, External quality assessment for KRAS testing is needed: setup of a European program and report of the first joined regional quality assessment rounds. Oncologist. 2011;16:467-78.
4: van Krieken JH. KRAS mutation testing for predicting response to anti-EGFR therapy for colorectal carcinoma: proposal for an European quality assurance program. Virchows Arch. 2008;453:417-31.

CV

Han van Krieken is a pathologist with special expertise in the fields of hematopathology and the pathology of the gastrointestinal tract. He was professor for tumor pathology since 1999 and is since 2005 keeping the chair of pathology and head of the department of pathology at the Radboud University Nijmegen Medical Centre in Nijmegen. He furthermore serves as Chairman of the Board of the Oncology Institute of the Radboud University Nijmegen.
He was the treasurer/secretary of the European Association for Hematopathology from 2000-2008 and from 2003-2011 the treasurer of the European Society for Pathology (ESP); he is presently the president of the ESP. Furthermore he coordinates the ESP quality assessment program. He is (co)author of more than 400 papers in peer reviewed journals, has written chapters in books on pathology and oncology, is editor of a Dutch Textbook on oncology and serves on the editorial board of the American Journal of Surgical Pathology and the Journal of Pathology, is managing editor of Virchows Archive and is the Chief editor of the Journal of Hematopathology. Since 2011 he is member of the German Academy of Sciences Leopoldina and since 2014 of Academia Europea and Honorary Fellow of the Royal Society of Pathology of Great Britain and Ireland.

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