J Thorac Oncol. 2013 Apr 11. [Epub ahead of print]
Results of the First Italian External Quality Assurance Scheme for Somatic EGFR Mutation Testing in Non-Small-Cell Lung Cancer.
*Research Department, Cell Biology and Biotherapy Unit, INT Fondazione "G.Pascale," Naples, Italy; †Pharmacogenomic Laboratory, CROM-Centro Ricerche Oncologiche di Mercogliano, Mercogliano, Avellino, Italy; ‡Department of Etimology, Laboratory of Oncology and Medicine, Medical Oncology, S. Orsola-Malpighi Hospital, Bologna, Italy; §Department of Human Pathology and Oncology, University of Florence, Florence, Italy; ‖Department of Laboratory Medicine, Division of Pathology, Ospedale Niguarda Ca' Granda, Milan, Italy; ¶Department of Pathology and Laboratory Medicine, European Institute of Oncology, Milan, Italy; #Department of Pathology and Cytodiagnostics, IRCCS Policlinico S.Donato and Casa di Cura S. Pio X, Milan, Italy; and **Center of Predictive Molecular Medicine, Center of Excellence on Aging, University-Foundation, Chieti, Italy.
INTRODUCTION:: The Italian Association of Medical Oncology (AIOM) and the Italian Society of Pathology and Cytology organized an external quality assessment (EQA) scheme for EGFR mutation testing in non-small-cell lung cancer. METHODS:: Ten specimens, including three small biopsies with known epidermal growth factor receptor (EGFR) mutation status, were validated in three referral laboratories and provided to 47 participating centers. The participants were requested to perform mutational analysis, using their usual method, and to submit results within a 4-week time frame. According to a predefined scoring system, two points were assigned to correct genotype and zero points to false-negative or false-positive results. The threshold to pass the EQA was set at higher than 18 of 20 points. Two rounds were preplanned. RESULTS:: All participating centers submitted the results within the time frame. Polymerase chain reaction (PCR)/sequencing was the main methodology used (n = 37 laboratories), although a few centers did use pyrosequencing (n = 8) or real-time PCR (n = 2). A significant number of analytical errors were observed (n = 20), with a high frequency of false-positive results (n = 16). The lower scores were obtained for the small biopsies. Fourteen of 47 centers (30%) that did not pass the first round, having a score less than or equal to 18 points, used PCR/sequencing, whereas 10 of 10 laboratories, using pyrosequencing or real-time PCR, passed the first round. Eight laboratories passed the second round. Overall, 41of 47 centers (87%) passed the EQA. CONCLUSION:: The results of the EQA for EGFR testing in non-small-cell lung cancer suggest that good quality EGFR mutational analysis is performed in Italian laboratories, although differences between testing methods were observed, especially for small biopsies.
- [PubMed - as supplied by publisher]