1,721,087 research outputs found
From volume to value: A watershed moment for the clinical laboratory
No full textThe clinical laboratory is often evaluated for the volume of testing. However, it is undeniable that laboratory tests affect clinical decision-making and are included in many clinical guidelines, meaning their contribution to determining clinical outcomes. Therefore, the clinical laboratory professional has the task of enhancing laboratory tests by optimizing the request and reporting phase and addressing patient outcomes. This opinion paper, presenting practical examples of managing value-based health care in the clinical laboratory context, underlines the need to shift towards value-based management to optimize outcome-based health care
Varianti geniche dell’MBL: un vantaggio o un freno all’invecchiamento di successo?
No full textOne4two®: An integrated molecular approach to optimize infertile couples’ journey
No full textThe current diagnostic path of infertile couples is long lasting and often ineffective. Genetic tests, in particular, appear as a limiting step due to their jeopardized use on one side, and to the limited number of genes evaluated on the other. In this context, the development and diffusion, also in routine diagnostic settings, of next generation sequencing (NGS)-based methods for the analyses of several genes in multiple subjects at a time is improving the diagnostic sensitivity of molecular analyses. Thus, we developed One4Two®, a custom NGS panel to optimize the diagnostic journey of infertile couples. The panel validation was carried out in three steps analyzing a total of 83 subjects. Interestingly, all the previously identified variants were confirmed, assessing the analytic sensitivity of the method. Moreover, additional pathogenic variants have been identified underlying the diagnostic efficacy of the proposed method. One4Two® allows the simultaneous analysis of infertility-related genes, disease-genes of common inherited diseases, and of polymorphisms related to therapy outcome. Thus, One4Two® is able to improve the diagnostic journey of infertile couples by simplifying the whole process not only for patients, but also for laboratories and reproduction specialists moving toward an even more personalized medicine. View Full-Text
Il ruolo dei geni modulatori nella patogenesi della Fibrosi Cistica.
No full textSelezionato per la comunicazione orale. Premio per la migliore comunicazione al Convegno
Il ruolo dei geni modulatori nella patogenesi della Fibrosi Cistica.
No full textSelezionato per la comunicazione orale. Premio per la migliore comunicazione al Convegno
The novelties of the regulation on health technology assessment, a key achievement for the European union health policies
No full textHealth technology assessment is a key tool for ensuring healthcare quality, accessibility, and sustainability. The novel European Union (EU) Health Technology Assessment (HTA) regulation of 15 December 2021, in harmonizing the laws of the Member States about the procedures and criteria for the evaluation of health technologies (i.e., medical devices and in vitro diagnostic tools), constitutes a significant achievement in the definition of EU health policies. On the one hand, for the European Union, it constitutes an essential driving force for the development of a competitive market for health technologies and, on the other, for European citizens, it guarantees the application of superordinate safety and quality standards with an impact positive on access to health technologies, including expressly also in vitro diagnostic medical devices classified in class D by art. 47 of Reg. (EU) 2017/746. As pointed out by the European Commissioner for Healthcare, the regulation identifies a new way for the Member States to cooperate on healthcare matters in the Union. The clinical efficacy and safety of drugs and devices are legal assets that today find their protection in a binding and directly applicable regulatory instrument, superordinate in the hierarchy of sources. Implementing the regulation will also be essential to achieve the objectives of the Union's pharmaceutical strategy and the European plan to fight cancer. The novel HTA European regulation, applicable from January 2025, will ensure inclusion and transparency in evaluating health technologies and increase the predictability of decisions for both Member State authorities and industry
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