European Consensus Conference for external quality assessment in molecular pathology

J. H. van Krieken, A. G. Siebers, N. Normanno

Research output: Contribution to journalArticle

30 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)1958-1963
Number of pages6
JournalAnnals of Oncology
Volume24
Issue number8
DOIs
Publication statusPublished - Aug 2013

Fingerprint

Molecular Pathology
Consensus
Guidelines
Drug Industry
Proxy
Prescriptions
Communication
Databases
Therapeutics
Pharmaceutical Preparations
Neoplasms
Pathologists
Oncologists

Keywords

  • External quality assessment
  • Guideline
  • Molecular pathology
  • Oncology

ASJC Scopus subject areas

  • Oncology
  • Hematology

Cite this

European Consensus Conference for external quality assessment in molecular pathology. / van Krieken, J. H.; Siebers, A. G.; Normanno, N.

In: Annals of Oncology, Vol. 24, No. 8, 08.2013, p. 1958-1963.

Research output: Contribution to journalArticle

van Krieken, J. H. ; Siebers, A. G. ; Normanno, N. / European Consensus Conference for external quality assessment in molecular pathology. In: Annals of Oncology. 2013 ; Vol. 24, No. 8. pp. 1958-1963.
@article{408756b0651e4071bb69554a71bfef90,
title = "European Consensus Conference for external quality assessment in molecular pathology",
abstract = "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.",
keywords = "External quality assessment, Guideline, Molecular pathology, Oncology",
author = "{van Krieken}, {J. H.} and Siebers, {A. G.} and N. Normanno",
year = "2013",
month = "8",
doi = "10.1093/annonc/mdt153",
language = "English",
volume = "24",
pages = "1958--1963",
journal = "Annals of Oncology",
issn = "0923-7534",
publisher = "NLM (Medline)",
number = "8",

}

TY - JOUR

T1 - European Consensus Conference for external quality assessment in molecular pathology

AU - van Krieken, J. H.

AU - Siebers, A. G.

AU - Normanno, N.

PY - 2013/8

Y1 - 2013/8

N2 - 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.

AB - 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.

KW - External quality assessment

KW - Guideline

KW - Molecular pathology

KW - Oncology

UR - http://www.scopus.com/inward/record.url?scp=84881255645&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84881255645&partnerID=8YFLogxK

U2 - 10.1093/annonc/mdt153

DO - 10.1093/annonc/mdt153

M3 - Article

C2 - 23613479

AN - SCOPUS:84881255645

VL - 24

SP - 1958

EP - 1963

JO - Annals of Oncology

JF - Annals of Oncology

SN - 0923-7534

IS - 8

ER -