Development of Diagnostic Kit for the Diagnosis of Bacteria related to Osteoarthritis

The project consists of an interplay between kit design, clinical testing and a verification study. The most important part, at an early stage, is to get enough patient material for the study to give statistically good results. After realising from earlie r studies that "getting enough samples in the right time" is a problem, we have designed a sampling plan that involves collecting samples from a number of hospitals in the Oslo area. This work will be coordinated by Professor Olav Reikerås at Rikshospital et, Oslo. SF and CAR samples, will be collected from surgery going on at the different hospitals. The samples will at all times be treated with sterile technique. When collected at Rikshospitalet, the samples will be split and sent for analysis at severa l different labs. The Orthopaedic Department at Iowa University Hospital will run most of the analyses using Orthogenics patent protected technology (primers PCR-setup). The Iowa lab is among the worlds best on cartilage-related molecular biology analys es. Another aliquot will be analysed, using the prototype, bacteria-specific kit, developed with an industrial partner. Either with Real-Time PCR technology from Artus GmbH, Hamburg, or from an alternative partner. The projects main focus is per today the verification study, different scenarios for the final kit-development process is being evaluated. The results from the studies will be collected and analysed by Orthogenics AS in Tromsø. Together with a technology partner (kit design and testing, s ales and marketing) Orthogenics will seek to provide a market-ready diagnostic kit based on this work in medio 2006. So far Orthogenics has had preliminary talks with Artus GmbH, which has expertise both in design, testing and production and in sales and marketing of diagnostic kits. Orthogenics AS has protected its commercial interests in the project through patent applications in EU, US, Canada and Australia.