The first swine brucellosis diagnostic test without the risk of false positives has a Spanish veterinary stamp
Researchers from the Aragón Agrifood Research and Technology Center (CITA), the University of Navarra, and the University of León have presented an immunological test for intradermal application for the diagnosis of brucellosis in pigs. The test, called Brucellin Aquilón, has been developed from the research of José María Blasco and Pilar M. Muñoz, from CITA, and Ignacio Moriyón and Raquel Conde, from the University of Navarra, and was presented to the European Agency for the Medicamento (EMA) by the Aquilón company, spinoff of the Infectious Diseases Group of the Veterinary Faculty of the University of León, led by Dr. Pedro Rubio and made up of the group's researchers, with the participation of the ULE and the Janus Project company.
Brucellosis is a disease that affects the reproduction of cows, goats, sheep, pigs, and other mammals, caused by different species of bacteria of the genus Brucella. It is a zoonosis, as it can be transmitted to humans and cause intermittent fevers, joint pain and other symptoms, known as Maltese Fevers, which can get complicated. For this reason, it is mandatory to declare, with serological diagnosis being a key element of disease eradication programs throughout the world.
The Brucellin Aquilón test is obtained from a type strain of the Brucella abortus bacterium that has been genetically modified so that it does not cause the cross reactions that generate false positives in the diagnostic tests for porcine brucellosis available until now. If approved, it would be the first diagnostic test for swine brucellosis free from the risk of false positives available worldwide.
No false positives
It is important to note that current serological diagnostic methods, developed and approved mainly for cattle, sheep, goats and pigs can give false positive results in up to 15% of the tests performed. These false positives generate heavy economic losses due to the need to euthanize the presumably infected serologically positive animals, which are frequently reproducers of high genetic value.
Aquilón has invested close to a million euros in its development and industrialization until completing the necessary documentation to carry out the registration. As it is a complex immunological product aimed at a notifiable disease, in its development the dialogue and constant support of the Spanish and European Medicines Agencies has been essential, as well as the scientific and technical advice of the research teams on brucellosis from the University of Navarra and CITA de Aragón. Manufacturing on an industrial scale has been possible thanks to close collaboration with CZ Veterinaria, from the Zendal group in O Porriño, Pontevedra.
Dr. Marta García Díez, director of the project in Aquilón, affirms that "managing to assemble a centralized registry for an immunological product with the characteristics of Brucellin Aquilon is a milestone not only for a small company like Aquilón, but for any veterinary pharmaceutical company" .
For Paula Martínez, adviser on the development and registration of veterinary drugs, “this project has been an enormous challenge that began in 2015 with the application and approval of MUMS / Minor use status (product intended for a very specific and restricted use), and in constant dialogue with both the Spanish Medicines Agency and the veterinary section of the European Medicines Agency to agree on the clinical trials necessary to demonstrate the safety and efficacy of the product ”.
It will have a sure impact on the management of swine brucellosis
José María Blasco, a world-renowned brucellosis specialist and ad honorem researcher at CITA, affirms that Aquilón's product “satisfies a great need in the diagnosis of porcine brucellosis”, and trusts that “your interest will soon be recognized by the OIE ”. For his part, Ignacio Moriyón, a professor at the University of Navarra (where the genetically modified strain of Brucella was obtained that allowed the product to be developed) with extensive experience in these issues, does not hide his satisfaction at seeing many years of research transformed into a record that , if approved, "will have a certain impact on the management of swine brucellosis throughout the world."
Dr. Lucía Dieste, a researcher whose doctoral thesis made it possible to validate the concept of the product for the first time, also expressed her joy at seeing her thesis potentially converted “into a box that can be distributed to veterinarians around the world for its systematic application in the management of brucellosis ”.
For Luis Ruiz Ávila, Aquilón director, the project is “a clear example of how the generation of knowledge in academic environments can be brought to the market thanks to close collaboration with small, spin-off companies capable of achieving major milestones with teams reduced and focused, with the support of key suppliers and the support of investors who are committed to supporting innovation, such as the Seguranza fund promoted by the Junta de Castilla y León and managed by Clave, investors from Alentia Capital or industrial companies such as Grupo Labiana and Grupo Ferrer who have given Aquilón the necessary financial support to achieve this development ”.
For Ruiz-Ávila, one of the key success factors of the project has been “collaboration with people such as Joan Marca (initiator and supporter of the project from Aquilón's operations management) or Thierry Pobel (in the statistical analysis); with the company Test and Trials (for the design and execution of the complex safety and efficacy tests required), and notably the involvement from the beginning of the company CZVeterinaria, which contributed all its experience to achieve the industrialization of the product, complying with all the necessary quality 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 Aragón.
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