PrediCTC, liquid biopsy in precision oncology: a technology transfer experience in the Spanish health system.

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PrediCTC, liquid biopsy in precision oncology: a technology transfer experience in the Spanish health system.

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Título: PrediCTC, liquid biopsy in precision oncology: a technology transfer experience in the Spanish health system.
Autor: Alonso Alconada, Lorena; Barbazan, Jorge; Candamio, Sonia; Falco, Josep Lluis; Antón Rodríguez, Cristina; Martín Saborido, Carlos; Fuster, Gustavo; Sampedro, Mabel; Grande, Carlos; Lado, Rubén; Sampietro Colom, Laura; Crego, Eladio; Figueiras, Sergio; León Mateos, Luis; López López, Rafael; Abal, Miguel
Resumen: 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.
Identificador universal: http://hdl.handle.net/10641/1365
Fecha: 2017


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