Pioneering test for false positive-free diagnosis of swine brucellosis

Scientists from the University have participated in the creation of a pioneering test for the diagnosis of porcine brucellosis without false positives. The diagnostic test , developed by business Aquilón, spin off of the University of León, has been registered with the European Medicines Agency (EMA).

The Aquilón Brucellin test, an immunological diagnostic test for intradermal application, test , has been developed by Aquilón based on the research of doctors José María Blasco and Pilar M. Muñoz, from the Centro de Investigación y Tecnología Agroalimentaria de Aragón, and Ignacio Moriyón and Raquel Conde, from the University of Navarra.

Brucellosis is a reproductive disease of cattle, goats, sheep and pigs caused by bacteria of the genus Brucella. It is a zoonosis, as it can be transmitted to humans and cause the picture of intermittent fevers and other symptoms known as malt fevers. It is therefore notifiable and diagnosis is a central element of disease eradication programmes worldwide.

Current serological diagnostic methods, developed and approved primarily for cattle, can give false positive results in up to 15% of the tests performed. These false positives are due to cross-reactions with other non-pathogenic bacteria that are often present on farms, and generate heavy economic losses due to the need to slaughter presumably infected animals.

A pioneering product resulting from collaboration between researchers and companies

The test is derived from a strain subject of Brucella abortus bacteria that has been genetically modified so that it does not cause the cross-reactions that cause false positives in available diagnostic tests. If approved, it would be the first brucellosis diagnostic test worldwide free of the risk of false positives available .

Aquilón, business Spin-off of the University of León, licensed the technology from the University of Navarra and CITA Aragón in 2015. Since then, it has invested nearly one million euros in its development and industrialisation until fill in the necessary information for registration. As this is a complex immunological product aimed at a notifiable disease, the dialogue and constant support of the Spanish and European Medicines Agencies, as well as the scientific and technical advice of the brucellosis research teams of the University of Navarra and CITA Aragón, has been fundamental in its development . Industrial scale manufacturing has been possible thanks to the close collaboration with CZ Veterinaria, from group Zendal in O Porriño, Pontevedra.

Dr Marta García Díez, director of project at Aquilon, says that managing to assemble a centralised registration for an immunological product with the characteristics of Brucellin Aquilon is a milestone not only for a small business like Aquilon, but for any veterinary pharmaceutical business . For Paula Martínez, consultant at development and registration of veterinary medicines, this project has been a huge challenge that started in 2015 with the application and approval of the MUMS/ Minor Use status (product intended for a very specific and restricted use), and in the constant dialogue with both the Spanish Medicines Agency and the veterinary section of the European Medicines Agency to agree on the clinical trials needed to demonstrate the safety and efficacy of the product.

José María Blasco, a world-renowned brucellosis specialist and researcher ad honorem at CITA, says that Aquilón's product meets a great need in brucellosis diagnostics, and is confident that it will soon be recognised by the OIE. Ignacio Moriyón, researcher of the University of Navarra (where the genetically modified strain of Brucella was obtained that allowed the product to be developed), with his extensive experience in these matters, does not hide his satisfaction at seeing many years of research transformed into a registry that, if approved, will have a definite impact on the management of swine brucellosis throughout the world. Lucía Dieste, the researcher whose doctoral dissertation enabled the product concept to be validated for the first time, also expressed her joy at seeing her thesis potentially turned "into a little box that can be distributed to veterinarians all over the world for its systematic application in the management of brucellosis".

For Luis Ruiz Ávila, director of Aquilón, project is a clear example of how the generation of knowledge in academic environments can be taken to the market thanks to the close cooperation partnership with small companies, from profile spin-offs, capable of achieving major milestones with small and focused teams, with the support of suppliers core topic. For Ruiz-Ávila, one of the factors core topic of the success of project has been the partnership with people like Joan Marca (initiator and supporter of project from the operations management of Aquilón), Thierry Pobel (in the statistical analysis); with the business Test and Trials (for the design and execution of the complex safety and efficacy tests required), and especially the involvement from the beginning of the business CZVeterinaria, which provided all its experience to achieve the industrialisation of the product while complying with all the necessary quality requirements requirements.

If approved, the product will be exploited by Aquilón and part of the profits will revert to the institutions of origin (the University of Navarra and the CITA of Aragon).