Phase 3 suppliers will validate their approved analytical solution on the oncNGS and demonstrate the clinical validity of the solution following the protocol approved in Phase 2 and authorized by the relevant ethical committees and all the other authorizing entities/agencies.
During the clinical validations, oncNGS solutions will be tested in parallel of the current routine panels used in the clinical practice. Clinical validation is the association between the test result and a clinical outcome, including the variability of a marker in subjects associated with a disease condition.
At the end of Phase 3, if the Buyers are satisfied with the results they will apply their best effort to ensure that such products are procured by means of the correspondent commercial procurement procedures, that will be opened to all the interested companies, according to their respective public procurement legislations.
Overall duration: 18 months
Execution : 15 months