Resumen de PrediCTC, liquid biopsy in precision oncology: a technology transfer experience in the Spanish health system
Lorena Alonso Alconada, Jorge Barbazán García, Sonia Candamio Folgar, Josep Lluís Falcó, Cristina Antón Rodríguez, Carlos Martín Saborido, Gustavo Fúster Olaguibel, Mabel Sampedro Parada, Carlos maría Grande Ventura, R. Lado, Laura Sampietro-Colom, Eladio Crego Gil, Sergio Figueiras Gómez, Luis León Mateos, Rafael López López, Miguel Abal Posada
Purpose Management of metastatic disease in oncology includes monitoring of therapy response principally by imaging techniques like CT scan. In addition to some limitations, the irruption of liquid biopsy and its application in personalized medicine has encouraged the development of more efficient technologies for prognosis and follow-up of patients in advanced disease.
Methods PrediCTC constitutes a panel of genes for the assessment of circulating tumor cells (CTC) in metastatic colorectal cancer patients, with demonstrated improved efficiency compared to CT scan for the evaluation of early therapy response in a multicenter prospective study. In this work, we designed and developed a technology transfer strategy to define the market opportunity for an eventual implementation of PrediCTC in the clinical practice.
Results This included the definition of the regulatory framework, the analysis of the regulatory roadmap needed for CE mark, a benchmarking study, the design of a product development strategy, a revision of intellectual property, a cost-effectiveness study and an expert panel consultation.
Conclusion The definition and analysis of an appropriate technology transfer strategy and the correct balance among regulatory, financial and technical determinants are critical for the transformation of a promising technology into a viable technology, and for the decision of implementing liquid biopsy in the monitoring of therapy response in advanced disease.
