PrediCTC, liquid biopsy in precision oncology: a technology transfer experience in the Spanish health system
Clin. transl. oncol. (Print)
; 20(5): 630-638, mayo 2018. ilus
Artículo
en Inglés
| IBECS
| ID: ibc-173540
Biblioteca responsable:
ES1.1
Ubicación: BNCS
ABSTRACT
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
RESUMEN
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Colección:
Bases de datos nacionales
/
España
Base de datos:
IBECS
Asunto principal:
Biopsia
/
Medicina de Precisión
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Oncología Médica
/
Células Neoplásicas Circulantes
Tipo de estudio:
Ensayo clínico controlado
/
Estudio observacional
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Estudio pronóstico
/
Factores de riesgo
Límite:
Humanos
Idioma:
Inglés
Revista:
Clin. transl. oncol. (Print)
Año:
2018
Tipo del documento:
Artículo
Institución/País de afiliación:
Antares Consulting/Spain
/
Clinic Hospital/Spain
/
EFT Consulting/Spain
/
Galician Health System (SERGAS)/Spain
/
Galician Network/Spain
/
Hoffmann Eitle/Spain
/
Ramon Dominguez Foundation/Spain
/
Universidad Francisco de Vitoria/Spain