Next generation diagnostic molecular pathology: Critical appraisal of quality assurance in Europe

Hendrikus J. Dubbink, Zandra C. Deans, Bastiaan B.J. Tops, Folkert J. van Kemenade, S. Koljenović, Han J.M. van Krieken, Willeke A.M. Blokx, Winand N.M. Dinjens, Patricia J.T.A. Groenen

Research output: Contribution to journalReview articlepeer-review

42 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)830-839
Number of pages10
JournalMolecular Oncology
Volume8
Issue number4
DOIs
Publication statusPublished - 1 Jun 2014
Externally publishedYes

Keywords

  • Molecular pathology
  • Next generation sequencing
  • Proficiency testing
  • Quality assessment
  • Quality assurance
  • Tumor testing

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