In the last years remarkable advances have been made in molecular diagnostics in cancer. With the identification of newer predictive biomarkers and the development of new precision drugs, the complexity of the molecular analyses required for cancer patients is continuously growing. The external quality assessment (EQA) programs play a pivotal role to ensure that laboratories perform reliable and accurate molecular tests, which are compulsory to determine the eligibility of the patients for targeted treatments. In this scenario, the Italian Association of Medical Oncology (AIOM) and the Italian Society of Pathology and Cytology (SIAPEC) organize different EQA schemes in order to evaluate inter-laboratory reproducibility of the molecular analyses performed through Italy.
AIOM-SIAPEC EQA programmes include the following biomarkers:
– RAS as predictive biomarkers in metastatic Colorectal Carcinoma (CRC); this scheme includes also the identification of BRAF mutations.
– EGFR mutation testing scheme in Non-Small Cell Lung Cancer (NSCLC).
– ALK rearrangements in NSCLC.
– BRAF mutational status in melanoma.
The organization of EQA schemes highlight weaknesses in the methodologies and operating procedures used in the molecular diagnostic laboratories, contributing to identify analytic and interpretive errors that might elude internal QA processes.
Also, AIOM and SIAPEC together help laboratories update their procedures and improve molecular testing providing continued education and a number of training courses and publishing constantly updated guidelines for the mutational analyses.
For any further information, please refer to the AIOM and SIAPEC website.