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In recent years, translational research achieved great success in identifying promising biomarkers.As a result, molecular pathology laboratories are now increasingly solicited to perform molecular tests to predict favourable response to targeted therapy, provide information about patient long-term survival and identify the status of genes that correlate with treatment resistance.Exciting as they may be, these new developments are being introduced in clinical practice at an accelerated pace which often leaves very little time for pathologists to set up robust and validated assays.Yet, Quality Assurance (QA) and Quality Control (QC) programs are indispensable for patient safety.Given the efficacy of these new molecules, it is of the outmost importance not to exclude patients that could benefit from a particular treatment.On the other hand, since many of the recently introduced drugs are often costly and may be associated with serious ontowards side effects, it is vital to avoid false positive results on those tests.Regulatory agencies in the US consider that most prognostic and predictive immunohistochemical tests (IHC tests) fall into class Ⅱ category.For that class Ⅱ tests strict adherence to national/international consensus guidelines that address pre-analytical, analytical and post-analytical variables is mandatory.As will be described during the talk, failure to implement an appropriate QA/QC program before providing a testing service can result in misdiagnoses leading to unnecessary, harmful and aggressive therapy or inadequate treatment.