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European Consensus Conference for external quality assessment in molecular pathology

2013; Elsevier BV; Volume: 24; Issue: 8 Linguagem: Inglês

10.1093/annonc/mdt153

1569-8041

J. Han van Krieken, Albert G. Siebers, Nicola Normanno, Fiona Blackhall, Elke Boone, Gerardo Botti, Fátima Carneiro, İ̇lhami Çelik, Fortunato Ciardiello, F Magrassi, A Lanzara, Ian A. Cree, Zandra C. Deans, Elisabeth Dequeker, Anders Edsjö, Patricia J.T.A. Groenen, Outi Kämäräinen, Hans Kreipe, J. Han van Krieken, Marjolijn J. L. Ligtenberg, Antonio Marchetti, Samuel Murray, Nicola Normanno, Frank J.M. Opdam, Scott D. Patterson, Simon Patton, Carmine Pinto, Etienne Rouleau, Ed Schuuring, Albert G. Siebers, Silke Sterck, Miquel Tarón, Sabine Tejpar, Wim Timens, Erik Thunnissen, Peter M. van de Ven,

Statistical Methods in Clinical Trials

Molecular testing of tumor samples to guide treatment decisions is of increasing importance. Several drugs have been approved for treatment of molecularly defined subgroups of patients, and the number of agents requiring companion diagnostics for their prescription is expected to rapidly increase. The results of such testing directly influence the management of individual patients, with both false-negative and false-positive results being harmful for patients. In this respect, external quality assurance (EQA) programs are essential to guarantee optimal quality of testing. There are several EQA schemes available in Europe, but they vary in scope, size and execution. During a conference held in early 2012, medical oncologists, pathologists, geneticists, molecular biologists, EQA providers and representatives from pharmaceutical industries developed a guideline to harmonize the standards applied by EQA schemes in molecular pathology. The guideline comprises recommendations on the organization of an EQA scheme, defining the criteria for reference laboratories, requirements for EQA test samples and the number of samples that are needed for an EQA scheme. Furthermore, a scoring system is proposed and consequences of poor performance are formulated. Lastly, the contents of an EQA report, communication of the EQA results, EQA databases and participant manual are given.