A four steps R&D process

Closely linked to care centers, benefiting from a privileged access to biological samples 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 4-step process to span all stages leading from the identification of a diagnostic test to its marketing in a quality and timely manner.

Evaluation of potential biomarkers

Research & Development, Marketing and Medical Affairs departments identify and validate candidate biomarkers and technologies of high medical and commercial value. IPSOGEN then negotiates a license agreement or files for patent protection.

Assay development

Following a short feasibility phase, R&D develops a prototype assay and verifies its performances under Design Control then proceeds to transfer to manufacturing.

Validation and clinical trials

A complete documentation is set-up to build and control pilot lots that are used in internal and external multi-centric validations to demonstrate that customer’s requirements are met. Clinical trials are conducted on the final version of the test.

Compliance  & regulatory

Since IPSOGEN’s Product Development Process follows the ISO13485 standard and FDA 21 CFR 820.30 regulation, our products can be CE marked and submitted to the FDA for commercialization in the USA.