Periodic Reporting for period 1 - CYTOPRO (Profiling of tumour cells in blood for personalized treatment of metastatic cancer)
Periodo di rendicontazione: 2015-10-01 al 2015-10-31
Objective 1. Identify possible laboratories and other CTC profiling partners with similar capabilities providing single cell PCR analyses and formulate possible joint business strategies.
Objective 2. Map out regulatory conditions to be met for an integrated device.
Objective 3. Design of strategy and clinical trial partnerships for clinical trials with the Cancer Institute at Erasmus University Medical Center, Rotterdam.
In search for CTC profiling partners, a ‘CTC WGA Module’ that allows routine clinical laboratories to use existing KRAS diagnostic kits hereby circumventing the need for business partners was defined (objective 1). On this basis, a regulatory analysis for CTC KRAS characterization has been performed defining the EU and US regulatory pathway, study protocols, data management, ethic considerations and device QA requirements (objective 2) and a clinical validation study has been designed in collaboration Erasmus University Medical Center Rotterdam involving three clinical trial sites across EU (objective 3).
The business plan has been updated with the CTC KRAS business case and now comprises a clear path towards clinical validation and subsequent regulatory approval of an in vitro diagnostic CTC KRAS diagnostic solution. On this basis, a Horizon 2020 phase 2 grant application has been prepared.