E!5727 New immunoassay technology for acute phase proteins for all mammals

Gentian's New Immunoassay Technology for acute phase proteins for all mammals is a Eurostars funded project involving Gentian Technology AS, the Swedish University of Agriculture in Uppsala and The scil animal health company GmbH in Germany. The aim of the project is research on the principle of generality in the design and creation of immunoassay. Today, an immunoassay is developed for a specific species, usually human, and the required mammalian antibody is harvested from another mammalian species. Al l immunoassays are species-specific. Gentian?s immunoassay development platform harvests avian antibodies from chicken eggs. Avian antibodies have different properties compared with mammalian antibodies. The ideas embedded in Gentian New Immunoassay Tech nology are in described in a Gentian patent, which was ratified by the European Patent Office in May 2011. Gentian's New Immunoassay Technology will be significant and important in the area of veterinary diagnostics. In the first instance, an approach is made to create general immunoassays for acute phase proteins that are important biomarkers for measuring animal health. CRP (C-reactive protein) is the most well known of many acute phase proteins. Research from the project will lead to a new and signi ficant commercial business. Landmark events in 2013 February 2013 Gentian Technology wins DNB?s regional innovation prize 2012 for Akershus and Østfold and receives a cash prize of 200.000 kroner. The prize is awarded for, ?an invention that can diagnose infection in animals, in this case dog.? March 2013: Gentian Technology wins third prize in the national final of DNB?s innovation prize 2012 and receives a further cash prize of 50.000 kroner. May 2013: Gentian Canine CRP turbidimetric imm unoassay is released for use in veterinary clinical laboratories. The reagent is being distributed by Gentians global distributor, The scil animal health company GmbH (www.scilvet.nl). The initial target market is within the boundaries of the EU/EEC. M ay 2013: Gentian present results at the project meeting in Uppsala that demonstrate generality in an SAA immunoassay for horse. The immunoassay works for both horse and dog. A project meeting will be held in Moss on December 17-18th 2013 where the pa rtners will discuss: 1. Ongoing trials at the University of Giessen where the CRP levels are measured in diseased dogs. The results of the study will be used in marketing the product. 2. Next steps in the testing of the Gentian Equine SAA turbidimetric immunoassay. 3. Universality of the SAA immunoassay in horse, dog and cat. 4. A review of immunoassays that Gentian are studying and the potential for veterinary use. 5. Release of scils immunoassay platform that includes the canine CRP immunoassay. The Canine CRP turbidimetric immunoassay is marketed by scil and is sold to veterinary laboratories for use on clinical chemistry platforms including; Architect 400, Beckman Olympus AU series, Roche Hitachi 917 and Advia 1800.

Background: Immunoassay-based diagnostics in veterinary medicine is hindered because antigens vary from species to species and immunoassay reagents used in human diagnostics cannot generally be used on other mammalian species. State-of-the-art: Immunoa ssays for human diagnostics are used occasionally in veterinary laboratories, however without specific calibration and only arbitrary units are reported. A few specialised products are available, for example, a CRP immunoassay from LifeAssays in 2009 diag noses inflammation in dogs. The assay is dog specific and will not work on other mammalian species. While a wide range of standard clinical chemistry diagnostic tests are available for in-house diagnostic use in veterinary clinics, only a very few immunol ogical parameters can be measured directly by the veterinarian in-house. Lateral flow immunoassays, which are easy to handle and deliver fast results, provide only qualitative results. To make more immunological parameters available for veterinary in-hous e diagnostics an easy to use and flexible method has to be developed which provides the vet with fast and reliable quantitative results. Three major obstacles must be overcome: 1. Immunoassays must be general so that one immunoassay serves all mammalia n species 2. Immunoassays must run on a simple-to-use, fool-proof, low-maintenance clinical chemistry platform requiring minimal operator training; and also run on other clinical chemistry platforms. 3. Immunoassays must be of robust design, homogeneous , non-separation-based and delivered in volumes that match the requirements of the modern veterinary practice. New immunoassay technology: Gentian has made a prototype nanoparticle-based CRP immunoassay that works on body fluids from all animals. Proof of principle has been obtained on CRP in dog, cat and swine. A patent application has been accepted. The technology will be demonstrated by developing at least 2 commercial general immunoassays - CRP and SAA.