Periodic Reporting for period 1 - platinDx (A test for predicting the efficacy of common platinum drugs enabling personalized chemotherapy for bladder cancer patients.)
Período documentado: 2015-05-01 hasta 2015-10-31
AMD undertook the feasibility study from May 1 to October 31 2015 with the objective to assess the commercial potential of their PlatinDx test and to outline a strategy for commercialisation in the EU.
AMD contacted potential partners for developing a manufacturing supply chain, clinical validation and regulatory approval of the test. We defined the clinical, drug substance and drug product, and mass spectrometry validation requirments.
We identified all of the required stakeholders for a Phase II project, confirmed the business case for commercialization of the test. Upon implementation, the test will improve the overall efficacy of chemotherapy and reduce needless suffering from toxic side effects while saving costs for the health care system at large, both in the EU and globally.