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
A feasibility study has been performed with focus on a global market analysis and the following three objectives from the grant agreement:
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.
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.
The global marked analysis has identified CTC KRAS characterization as an attractive business opportunity for the CytoTrack system with accumulated 5-year revenues of nearly €100 million. It is expected that CTC KRAS analysis from a blood sample will substitute invasive biopsies and improve personalized therapy of patients diagnosed with metastatic colorectal cancer.
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.
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.
The innovation project will propel Cytotrack into the clinical market with an estimated cumulated revenue of € 100 million five year after en of clinical trials. Our solution will depense of expensive and invasive needle biopsies. This results in more accurate testing, better patient wellfare and € 350 million in saved cost in the health sector.