Closely linked to care centers, benefiting from a privileged access to biological devices and clinical data from patients under treatment, public research on biomarker identification is a highly dynamic sector. Based on patents licensed from academic laboratories or invented by its own research team, Ipsogen has set up a 5-step process to span all stages leading from the identification of a diagnostic test to its marketing in less than a year.
Evaluation of potential biomarkers (up to 3 months)
The research and development, marketing and legal departments identify technologies and candidate tests and validate their diagnostic and commercial value. Ipsogen then negotiates a licensing agreement, files for patent protection and validates its expertise on the basis of study results.
Technology transfer (3-9 months)
The research and development department reproduces the results, validates product feasibility and implements improvements. This phase allows the start of design work and optimization of the manufacturing process.
Industrial development (3-6 months)
The research and development department creates a prototype and validates its analytical performance. The production and marketing departments then manufacture and market the product under RUO (Research Use Only) status.
Regulatory development (12-24 months)
The research and development department assesses the performance of the product marketed with RUO status and obtains CE marking and FDA authorization.
Post-marketing studies (up to 6 months)
The marketing department seeks to demonstrate the medical and clinical utility of the product in order to obtain reimbursement status from health organizations.
