Guidance for laboratories performing molecular pathology for cancer patients. Issue 11 (10th July 2014)

• Record Type: Journal Article
• Authors: Cree, Ian A; Deans, Zandra; Ligtenberg, Marjolijn J L; Normanno, Nicola; Edsjö, Anders; Rouleau, Etienne; Solé, Francesc; Thunnissen, Erik; Timens, Wim; Schuuring, Ed; Dequeker, Elisabeth; Murray, Samuel; Dietel, Manfred; Groenen, Patricia; Van Krieken, J Han
• Other Names: Barnardo Martin author non-byline.; Blackhall Fiona author non-byline.; Boone Elke author non-byline.; Botti Gerardo author non-byline.; Butler Rachel author non-byline.; Carneiro Fatima author non-byline.; Celik Ilhan author non-byline.; Ciardiello Fortunato author non-byline.; Collins Peter author non-byline.; Cotter Finbarr author non-byline.; Duecker Klaus author non-byline.; Finn Stephen author non-byline.; Hall Marta author non-byline.; Hodges Elizabeth author non-byline.; Jawaid Ansar author non-byline.; Jung Andreas author non-byline.; Kalsheker Noor author non-byline.; Kamarainen Outi author non-byline.; Kerr Keith author non-byline.; Kreipe Hans author non-byline.; Martin Jo author non-byline.; Marchetti Antonio author non-byline.; Marondel Ivonne author non-byline.; McCormack Rose author non-byline.; Miller Keith author non-byline.; Newland Adrian author non-byline.; Nowak Frederiqu author non-byline.; Opdam Frank author non-byline.; Patterson Scott author non-byline.; Patton Simon author non-byline.; Paul John author non-byline.; Pinto Carmine author non-byline.; Pokinskyj Peter author non-byline.; Prentice Archie author non-byline.; Salto-Tellez Manuel author non-byline.; Santucci Marco author non-byline.; Sapino Anna author non-byline.; Shaw Emily author non-byline.; Siebers Bert author non-byline.; Stahel Rolf author non-byline.; Stanta Giorgio author non-byline.; Szepessy Edit author non-byline.; Taron Miquel author non-byline.; Tejpar Sabine author non-byline.; Vassiliou George author non-byline.; Wells Mike author non-byline.; Wong Newton author non-byline.;
• Is Part Of: Journal of clinical pathology. Volume 67:Issue 11(2014)
• Page Start: 923
• Page End: 931
• Publication Date: 2014-07-10
• Subjects: Molecular Pathology -- Neoplasms -- Quality Control -- Laboratory Tests -- Molecular Oncology; Pathology -- Periodicals; Pathology, Molecular -- Periodicals; 616.0705
• DOI: 10.1136/jclinpath-2014-202404
• Languages: English
• ISSNs: 0021-9746

Abstract

Abstract : 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.