Guidance for laboratories performing molecular pathology for cancer patients

Ian A Cree, Zandra Deans, Marjolijn J L Ligtenberg, Nicola Normanno, Anders Edsjö, Etienne Rouleau, Francesc Solé, Erik Thunnissen, Wim Timens, Ed Schuuring, Elisabeth Dequeker, Samuel Murray, Manfred Dietel, Patricia Groenen, J Han Van Krieken, Manuel Salto-Tellez, European Society of Pathology Task Force on Quality Assurance in Molecular Pathology

Research output: Contribution to journalArticlepeer-review

115 Citations (Scopus)
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Molecular testing is becoming an important part of the diagnosis of any patient with cancer. The challenge to laboratories is to meet this need, using reliable methods and processes to ensure that patients receive a timely and accurate report on which their treatment will be based. The aim of this paper is to provide minimum requirements for the management of molecular pathology laboratories. This general guidance should be augmented by the specific guidance available for different tumour types and tests. Preanalytical considerations are important, and careful consideration of the way in which specimens are obtained and reach the laboratory is necessary. Sample receipt and handling follow standard operating procedures, but some alterations may be necessary if molecular testing is to be performed, for instance to control tissue fixation. DNA and RNA extraction can be standardised and should be checked for quality and quantity of output on a regular basis. The choice of analytical method(s) depends on clinical requirements, desired turnaround time, and expertise available. Internal quality control, regular internal audit of the whole testing process, laboratory accreditation, and continual participation in external quality assessment schemes are prerequisites for delivery of a reliable service. A molecular pathology report should accurately convey the information the clinician needs to treat the patient with sufficient information to allow for correct interpretation of the result. Molecular pathology is developing rapidly, and further detailed evidence-based recommendations are required for many of the topics covered here.

Original languageEnglish
Pages (from-to)923-31
Number of pages9
JournalJournal of Clinical Pathology
Issue number11
Publication statusPublished - Nov 2014


  • Benchmarking
  • Biomarkers, Tumor
  • Genetic Testing
  • Guideline Adherence
  • Humans
  • Laboratories
  • Medical Oncology
  • Medical Records
  • Neoplasms
  • Pathology, Molecular
  • Practice Guidelines as Topic
  • Predictive Value of Tests
  • Prognosis
  • Specimen Handling


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