TY - JOUR
T1 - Next generation diagnostic molecular pathology
T2 - Critical appraisal of quality assurance in Europe
AU - Dubbink, Hendrikus J.
AU - Deans, Zandra C.
AU - Tops, Bastiaan B.J.
AU - van Kemenade, Folkert J.
AU - Koljenović, S.
AU - van Krieken, Han J.M.
AU - Blokx, Willeke A.M.
AU - Dinjens, Winand N.M.
AU - Groenen, Patricia J.T.A.
N1 - Publisher Copyright:
© 2014 Federation of European Biochemical Societies.
PY - 2014/6/1
Y1 - 2014/6/1
N2 - 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.
AB - 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.
KW - Molecular pathology
KW - Next generation sequencing
KW - Proficiency testing
KW - Quality assessment
KW - Quality assurance
KW - Tumor testing
UR - http://www.scopus.com/inward/record.url?scp=84914162901&partnerID=8YFLogxK
U2 - 10.1016/j.molonc.2014.03.004
DO - 10.1016/j.molonc.2014.03.004
M3 - Review article
C2 - 24704265
AN - SCOPUS:84914162901
SN - 1574-7891
VL - 8
SP - 830
EP - 839
JO - Molecular Oncology
JF - Molecular Oncology
IS - 4
ER -