Open AccessNext generation diagnostic molecular pathology: Critical appraisal of quality assurance in Europe
Author(s) -
Dubbink Hendrikus J.,
Deans Zandra C.,
Tops Bastiaan B.J.,
van Kemenade Folkert J.,
Koljenović S.,
van Krieken Han J.M.,
Blokx Willeke A.M.,
Dinjens Winand N.M.,
Groenen Patricia J.T.A.
Publication year - 2014
Publication title -
molecular oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.332
H-Index - 88
eISSN - 1878-0261
pISSN - 1574-7891
DOI - 10.1016/j.molonc.2014.03.004
Subject(s) - molecular pathology , quality assurance , molecular diagnostics , medical physics , competence (human resources) , medicine , turnaround time , molecular biomarkers , pathology , diagnostic test , critical appraisal , external quality assessment , computer science , bioinformatics , oncology , psychology , biology , alternative medicine , social psychology , biochemistry , emergency medicine , gene , operating system
Tumor evaluation in pathology is more and more based on a combination of traditional histopathology and molecular analysis. Due to the rapid development of new cancer treatments that specifically target aberrant proteins present in tumor cells, treatment decisions are increasingly based on the molecular features of the tumor. Not only the number of patients eligible for targeted precision medicine, but also the number of molecular targets per patient and tumor type is rising. Diagnostic molecular pathology, the discipline that determines the molecular aberrations present in tumors for diagnostic, prognostic or predictive purposes, is faced with true challenges. The laboratories have to meet the need of comprehensive molecular testing using only limited amount of tumor tissue, mostly fixed in formalin and embedded in paraffin (FFPE), in short turnaround time. Choices must be made for analytical methods that provide accurate, reliable and cost‐effective results. Validation of the test procedures and results is essential. In addition, participation and good performance in internal (IQA) and external quality assurance (EQA) schemes is mandatory. In this review, we critically evaluate the validation procedure for comprehensive molecular tests as well as the organization of quality assurance and assessment of competence of diagnostic molecular pathology laboratories within Europe.