Date: 2014-09-24
Type of information: Completion of patient enrollment
phase:
Announcement: completion of patient enrollment
Company: Diaxonhit (France)
Product: BJI InoPlex™ test
Action
mechanism: BJI InoPlex ™ is a multiplex assay based on the detection in patient’s blood of antibodies targeting key bacterial antigens recognized by the immune system during prosthetic infections. Developed on the Luminex technology and using highly specific recombinant antigens, this test allows individual and simultaneous characterization of antibodies targeting four families of bacteria including staphylococci that represents 80% of infections. It requires a very small amount of serum obtained by simple blood draw and can be easilyrepeated. BJI InoPlex ™ is protected by several patents covering selected antigens as well as the algorithm for interpretation of results.
Disease: hip and knee replacement infections
Therapeutic area: Infectious diseases - Diagnostic
Country: France
Trial details:
Latest
news: * On September 24, 2014, Diaxonhit , a French leader in specialty in-vitro diagnostics, announces the completion of patient enrollment in its validation study of BJI InoPlex™, the first blood test for the diagnosis of hip and knee replacement infections. This validation study of the performance and clinical utility of the test was held in two reference centers for bone and joint Infections (CRIOA) in the Ile-de-France region (Croix Saint-Simon and Ambroise Pare hospitals). 470 patients were enrolled, including 200 patients whose prostheses were infected. The results of the study are currently being analyzed, and the final performance of BJI InoPlex™ is expected for the last quarter of 2014. CE marking the test is scheduled for December 2014.
BJI InoPlex™ would then be the first non-invasive blood test to support the diagnosis of prosthetic bone and joint infections. Through a simple process, it facilitates confirmation of an infection or not.
