A review on the Idylla platform: Towards the assessment of actionable genomic alterations in one day

Cancer still represents a major cause of death in the world. In the last decades, a better understanding of the molecular bases of cancer initiation, progression and antitumour immunity response escape has led to the development of new therapeutic strategies. Indeed, targeted treatments against oncogenic proteins and immune-checkpoint inhibitors have considerably improved quality of life and treatment outcomes of patients with cancer. Thus, assessment of predictive biomarker is crucial. According to the US Food and Drug Administration, a companion diagnostic assay, which provides essential information for the safe and effective use of a corresponding drug, is a unique medical device. Conversely, in the European Union the same biomarker can be analysed by using different diagnostic platforms, with different advantages and drawbacks. Nevertheless, any commercially available diagnostic assay needs to achieve validation, for approval by the European Community for in vitro diagnostic use (CE-IVD).