Next generation diagnostic molecular pathology: Critical appraisal of quality assurance in Europe. Issue 4 (18th March 2014)

• Record Type: Journal Article
• Authors: 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.
• Other Names: Spatz Alan specialEditor.; van Kempen Léon specialEditor.
• Is Part Of: Molecular oncology. Volume 8:Issue 4(2014:Jun.)
• Page Start: 830
• Page End: 839
• Publication Date: 2014-03-18
• Subjects: Molecular pathology -- Next generation sequencing -- Proficiency testing -- Quality assessment -- Quality assurance -- Tumor testing; Cancer -- Molecular aspects -- Periodicals; 616.994005
• DOI: 10.1016/j.molonc.2014.03.004
• Languages: English
• ISSNs: 1574-7891

Abstract

Abstract : 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. Highlights: Molecular pathology testing should be performed in ISO 15189‐accredited laboratories. Appropriately educated and dedicated personnel are essential. One dedicated organization that coordinates all EQA schemes will improve efficiency. The actions for laboratories after poor performance need standardization.