Guidance for laboratories performing molecular pathology for cancer patients
Open Access
- 10 July 2014
- journal article
- research article
- Published by BMJ in Journal of Clinical Pathology
- Vol. 67 (11), 923-931
- https://doi.org/10.1136/jclinpath-2014-202404
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.Keywords
This publication has 54 references indexed in Scilit:
- The molecular evolution of acquired resistance to targeted EGFR blockade in colorectal cancersNature, 2012
- Emergence of KRAS mutations and acquired resistance to anti-EGFR therapy in colorectal cancerNature, 2012
- The Genetic Basis for Cancer Treatment DecisionsCell, 2012
- Quantitative assessment shows loss of antigenic epitopes as a function of pre-analytic variablesLaboratory Investigation, 2011
- Circulating tumour markers can define patients with normal colons, benign polyps, and cancersBritish Journal of Cancer, 2011
- Formalin Fixation at Low Temperature Better Preserves Nucleic Acid IntegrityPLOS ONE, 2011
- Opening the archives for state of the art tumour genetic research: sample processing for array-CGH using decalcified, formalin-fixed, paraffin-embedded tissue-derived DNA samplesBMC Research Notes, 2011
- Approaches to quality management and accreditation in a genetic testing laboratoryEuropean Journal of Human Genetics, 2010
- Molecular basis of chemosensitivity of platinum pre-treated ovarian cancer to chemotherapyBritish Journal of Cancer, 2010
- Multicentre validation study of nucleic acids extraction from FFPE tissuesVirchows Archiv, 2010