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DIAGNOSIS OF AUTOIMMUNE DISEASES
Principal investigator and research findings
The Cellular and Molecular Neuroanatomy Laboratory of the Biology Department at the University of Trieste initially contacted SISTER to identify methods for the research group to protect their know-how in view of collaboration with a local pharmaceutical company on diagnostic systems for celiac disease.
The actions taken by AREA in this case provide an example of an enhancement process that managed to meet a variety of requirements arising in the course of its development. AREA experts' actions
Initially, coding the research group’s know-how to identify methods for protecting it widened the scope for prior-use and patentability assessments to include a diagnosis method applicable to all autoimmune pathologies.
In the meantime, the creation of a line of services and products for diagnosing autoimmune diseases of the nervous system has become the object of the “Neuroantigen” business project, winner of the 2004 StartCup Trieste. The research group developed the offer of a line of services and products conceived as a diagnostic pipeline, with a wide-spectrum initial screening followed by a second test on cell lines to identify disease families, and by a number of kits for the identification of individual diseases or interrelated disease groups.
On this premise, the AREA staff again took steps to define a strategy to protect intellectual property and to support the trial validation of the methodology.
The patentability assessment revealed a need for test results on a wide casuistics of diseases and/or cell lines in order to establish valid and enforceable industrial property rights.
The validation, currently underway at the University of Trieste Department of Biology, aims to identify the advantages of wide-spectrum screening and of cell lines use compared to standard techniques, with the purpose of confirming their representativeness and laying the foundations for their approval and dissemination in the scientific community.
Furthermore, the Cellular and Molecular Neuroanatomy Laboratory turned to SISTER for activities only partially related with the Neuroantigen project, in particular for support in drawing up a project to develop a kit to identify the BDNF (Brain-Derived Neurotrophic Factor) to be submitted to an industrial partner, and in handling the ensuing negotiation of contractual terms. In this case, AREA experts calculated the profitability of marketing the kits, providing the basis for the subsequent negotiations.
Research enhancement result
Thus far, the results of the validation have led to the publication of the wide-spectrum screening method in the Journal of Neuroimmunology Methods and to the presentation of two trial protocols for its clinical application at the Cattinara Neurological Clinic (Trieste) and IRCCS Stella Maris (Pisa).
The “Neuroantigen” project is currently a candidate for the Innovation Factory, to create a spin-off business based on the results of this research: the first step involves the provision of diagnostic services through wide-spectrum screening, followed – at the end of the trial period and after the beginning of the business activity - by the production and marketing of diagnostic kits for the individual diseases dealt with by the project.
The negotiation of the agreement for the development of a kit to identify the BDNF was successful. The client has indeed agreed to appropriately reward the Biology Department for R&D and to award royalties from the sale of products developed as part of the project. << back
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