Project: A robust veterinary point-of-care device for measuring canine CRP in the field.

Background: _x000D_Specific proteins are measured by immunoassay technology where a specific antibody binds to its specific antigen. Immunoassay-based diagnostics in veterinary medicine is complicated because antigens vary from species to species and immunoassay reagents used in human diagnostics cannot generally be used on other mammalian species. _x000D__x000D_State-of-the-art:_x000D_Immunoassays for human diagnostics are used occasionally in veterinary laboratories, however without specific calibration and only arbitrary units are reported. Immunoassays specific for animals are becoming available. For example, Eiken Chemical Co supplies an SAA immunoassay for horses and cats; and Gentian Technology will supply a specific canine C-reactive protein (CRP) and specific equine SAA in 2013. These immunoassays run on modern high-priced clinical chemistry instruments. _x000D_Lateral flow immunoassays, which are easy to handle and deliver fast results, provide limited quantitative measurements. _x000D_Some point-of-care (POC) tests are available, for example, a canine CRP immunoassay from LifeAssays in 2009 measures inflammation in dogs. The available POC devices are often not well suited to the rigors and time-constraints in the veterinary clinic. _x000D_However, POC delivers fast results in a diagnostic setting where results and monitoring are time-critical. POC cannot compete with centralized laboratories on price or reliability and centralized services will continue to be used in non-critical testing._x000D__x000D_Assumptions:_x000D_There is a consensus amongst veterinary clinicians that canine CRP is one of the most important veterinary immunoassay diagnostics for accurate detection and grading of systemic inflammatory activity. Further, the successful introduction and widespread use of a specific canine CRP immunoassay will open the market for other immunoassay diagnostics. The companion animal market will open up first and the production animal market will follow as the use of veterinary immunoassay diagnostics is proven and accepted._x000D__x000D_Challenges:_x000D_Raising veterinarian awareness of the benefits of modern immunoassay diagnostics requires a new approach that addresses the following requirements: _x000D_1. A robust and user-friendly POC device that works in the field and non-laboratory situations._x000D_2. A rapid, time-independent colorimetric method with reagents that give a test result within 2 minutes and where the color is stable for minimum 30 minutes. _x000D_3. A "killer application" - a specific canine CRP immunoassay POC offering fast and reliable quantitative results._x000D_4. Evidence based research that documents the clinical value of immunoassay diagnostic methods for the patient, and demonstrates significant cost saving for both owner and veterinarian. _x000D__x000D_Project Goals:_x000D_1. Development of an electricity-independent, vertical flow POC device for measuring wide ranges of canine CRP in the field. _x000D_2. Development of canine CRP immunoassay technology for use in same POC._x000D_3. Development of a colorimetric method to support quantitative colorimetric measurement of canine CRP._x000D_4. Documented clinical evidence to support a canine CRP POC as a useful veterinary diagnostic tool in the field. _x000D_5. Development of marketing strategies and plans to successfully launch canine CRP in the European and critical North American markets._x000D__x000D_Other Goals:_x000D_1. Establish a new POC technology for the veterinary market_x000D_2. Generate data to secure extended patent rights_x000D_3. Produce prototype immunoassays attractive for the veterinary market _x000D_4. Explore other market opportunities for a new POC technology, for example, medical diagnostics in the field in developing countries._x000D__x000D_Consortium Ps:_x000D_ _x000D_Gentian Technology AS is a Norwegian company with expertise in antibody and immunoassay technology. _x000D_Roles include: Project coordinator; design and development of immunoassay reagents and calibrators; reagent validation on multiple immunoassay platforms; and product and clinical documentation. _x000D_ _x000D_Norwegian Antibodies AS is a Norwegian company with expertise in antibody production. _x000D_Roles include: Design and development of POC device; antibody and immunoassay reagents; device validation, product specifications and production facilities. Field and technical studies; marketing plans and distribution. _x000D__x000D_Getica AB is a specialized biotech SME concentrating on bioorganic coupling chemistries and bioprocessing of protein conjugates and nanoparticles._x000D_Roles include: Design and development of nanoparticles for the colorimetric method. Preparation of antigens; preparation of antibodies; affinity chromatography of antibodies; and preparation of nanoparticles for reagent production._x000D_

Acronym	Tiny POC (Reference Number: 8470)
Duration	01/09/2013 - 31/08/2016
Project Topic	A patented point-of-care device with nanoparticle-based colorimetric reagents is invented. The device is electricity-independent, robust, fast, time-independent and user-friendly. Tiny POC is a true field method for quantitative measurement and usability is not limited to the veterinary field.
Network	Eurostars
Call	Eurostars Cut-Off 10

Project partner

Number	Name	Role	Country
3	Gentian Technology AS	Coordinator	Norway
3	Getica AB	Partner	Sweden
3	Norwegian Antibodies AS	Partner	Norway