Clinical Validation of In Vitro diagnostic devices
This phase will make it possible to empirically evaluate the clinical utility and the value added by the test to the care of patients. The validation will be positive if the results of the test enable taking quick and effective decisions, concerning the treatment and the provision of preventive measures to be implemented for the patients.
Objective indicators, qualitative or quantitative depending on the case, are established for evaluating the impact of marketing of the in vitro diagnostic device.
- The advanced analytics provided by the test (biomarker without precedent, companion diagnostic tests, equivalent to an earlier test bringing a new advantage, etc.)
- The clinical value of the result (impact on clinical decision making)
- The analytical reliability of the test in an actual clinical environment,
- The ease of incorporation of the in vitro diagnostic device in the course of patient care (method of sampling, routine time required to obtain results, etc.)
- The evaluation of its impact on the risks encountered by the healthcare personnel,
- The overall cost of production of the result (investments, fixed costs, variable costs, working hours of the health personnel).
- The quantification of the economic impact of the new in vitro diagnostic device on the health system,
- The appreciation of societal impact of the new test
This clinical information, combined with other validation data, is then compiled for preparing the regulatory file for the in vitro diagnostic device. For the European Union, these elements make it possible to obtain CE-IVD marking. For the USA, they allow you to submit a file for the approval of the FDA – Office of In Vitro Diagnostic Device – Evaluation and Safety. In all countries, these clinical data are indispensable for consideration with regard to reimbursement for the process of diagnosis by the health system.