title: Molecular genetics external quality assessment pilot scheme for KRAS analysis in metastatic colorectal cancer.
abstract: Laboratories are increasingly required to perform molecular tests for the detection of mutations in the KRAS gene in metastatic colorectal cancers to allow better clinical management and more effective treatment for these patients. KRAS mutation status predicts a patient's likely response to the monoclonal antibody cetuximab. To provide a high standard of service, these laboratories require external quality assessment (EQA) to monitor the level of laboratory output and measure the performance of the laboratory against other service providers. National External Quality Assurance Services for Molecular Genetics provided a pilot EQA scheme for KRAS molecular analysis in metastatic colorectal cancers during 2009. Very few genotyping errors were reported by participating laboratories; however, the reporting nomenclature of the genotyping results varied considerably between laboratories. The pilot EQA scheme highlighted the need for continuing EQA in this field which will assess the laboratories' ability not only to obtain accurate, reliable results but also to interpret them safely and correctly ensuring that the referring clinician has the correct information to make the best clinical therapeutic decision for their patient.
authors.affiliation: UK NEQAS for Molecular Genetics, Institute of Human Genetics, International Centre for Life, Central Parkway, Newcastle upon Tyne, United Kingdom. zandra.deans@nuth.nhs.uk
authors.forename: Zandra C
authors.initials: ZC
authors.lastname: Deans
authors.forename: Justyna
authors.initials: J
authors.lastname: Tull
authors.forename: Gemma
authors.initials: G
authors.lastname: Beighton
authors.forename: Stephen
authors.initials: S
authors.lastname: Abbs
authors.forename: David O
authors.initials: DO
authors.lastname: Robinson
authors.forename: Rachel
authors.initials: R
authors.lastname: Butler
mesh_terms: D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000068818:Cetuximab; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000235:genetics* / Q000473:pathology; D004252:DNA Mutational Analysis; D019008:Drug Resistance, Neoplasm / Q000235:genetics*; D005069:Evaluation Studies as Topic; D005260:Female; D006801:Humans; D008297:Male; D008967:Molecular Biology; D009154:Mutation; D009362:Neoplasm Metastasis; D010865:Pilot Projects; D011518:Proto-Oncogene Proteins / Q000235:genetics*; D016283:Proto-Oncogene Proteins p21(ras); D011785:Quality Assurance, Health Care; D006113:United Kingdom; D018631:ras Proteins / Q000235:genetics*
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; C117307:KRAS protein, human; D011518:Proto-Oncogene Proteins; D016283:Proto-Oncogene Proteins p21(ras); D018631:ras Proteins; D000068818:Cetuximab