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Final performance and CE marking expected before the end of 2014
- Commercial launch early 2015, strengthening Diaxonhit's diagnostic product offering in infectious diseases
PARIS, Sept. 24, 2014 (GLOBE NEWSWIRE) -- Diaxonhit (Alternext : ALEHT, FR0004054427), a French leader in specialty in-vitro diagnostics, announces the completion of patient enrollment in its validation study of BJI InoPlex(TM), 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(TM) is expected for the last quarter of 2014. CE marking the test is scheduled for December 2014.
BJI InoPlex(TM) 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.
Every year, approximately 3 million prostheses are implanted in Europe and the United States1. In France, approximately 221,000 hip and knee replacements were performed in 20122. This market is growing due to aging and growing obesity. Nearly 20% of all patients who undergo prosthetic surgery experience pain within a few days to a few months, and identification of its cause - mechanical or infectious - is a long, invasive and tedious process. Prosthetic infection is indeed a serious complication that requires rapid and relevant therapy including surgery and long-term antibiotic treatment to prevent chronic infection and severe sequelae. Identifying infections is also important to avoid administration of unnecessary antibiotics to patients whose pain is due to mechanical causes.
"Currently, the diagnosis of prosthetic infections is still too long. None of the available tools, whether clinical, radiological or biological, have a sensitivity and specificity of 100%. BJI InoPlex(TM) would complement and enrich this diagnostic arsenal by providing a quick response on the immune status of the patient with respect to the main pathogens found in this type of infection. This test should therefore improve the reliability of differential diagnosis between mechanical failure and prosthetic infection. It could also be quite useful for prognostic considerations as well as therapeutic follow-up", says Professor Jean-Louis Gaillard, head of the biology division of University Hospitals Paris Ile-de-France Ouest.
"BJI InoPlex is a blood test designed to provide orthopedic surgeons with a simple and non-invasive diagnostic complement. Once the final results of the study known in the next few weeks, BJI InoPlex would be the first blood test on the market to address this largely unmet medical need. This innovative test should strengthen our specialty in-vitro diagnostic offering in the field of infectious diseases, and extend our leadership beyond the transplantation market." concludes Loïc Maurel, M.D., President of the Management Board of Diaxonhit.
About BJI InoPlex(TM)
BJI InoPlex (TM) 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 easily repeated. BJI InoPlex (TM) is protected by several patents covering selected antigens as well as the algorithm for interpretation of results.
About DIAXONHIT
Diaxonhit (NYSE Alternext, FR0004054427, ALEHT) is a French fully integrated leader in the in vitro diagnostic field, involved from research to commercialization of specialty diagnostic products. With many partnerships and a strong presence in hospitals, Diaxonhit has an extensive commercialization network. Through its affiliate, InGen, it commercializes and services, mostly under exclusivity agreements, in-vitro diagnostic kits and advanced equipment. It operates mainly in the fields of transplantation, infectious diseases and autoimmunity, product quality control and rapid tests, including Tetanus Quick Stick ®, a proprietary product. InGen is the leading supplier in France of HLA tests manufactured by Thermo-Fisher/One Lambda, of which it is the largest distributor worldwide. The group also owns a diversified portfolio of products in development, including both innovative molecular and non-molecular diagnostics, covering three main specialty areas: transplantation, immuno-infection and cancer. Diaxonhit headquarters are located in Paris and its affiliate in the Paris region. The Group is listed on NYSE Alternext in Paris and is part of the NYSE Alternext OSEO innovation index.
For more information, please visit: http://www.diaxonhit.com
Symbol: ALEHT - ISIN Code: FR0004054427 - Reuters: ALEHT.PA - Bloomberg: ALEHT:FP
Disclaimer
This press release contains elements that are not historical facts including, without limitation, certain statements about future expectations and other forward-looking statements. Such statements are based on management's current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those anticipated.
In addition, Diaxonhit, its shareholders, and its affiliates, directors, officers, advisors and employees have not verified the accuracy of, and make no representations or warranties in relation to, statistical data or predictions contained in this press release that were taken or derived from third party sources or industry publications, and such statistical data and predictions are used in this press release for information purposes only.
Finally, this press release may be drafted in the French and English languages. If both versions are interpreted differently, the French language version shall prevail.
Contacts
DIAXONHIT
Hervé Duchesne de Lamotte, CFO, +33 (0)1 53 94 52 49, herve.delamotte@diaxonhit.com
NewCap
Julien Perez, Investors Relations & Financial Communication, +33 (0)1 44 71 98 52, jperez@newcap.fr
Annie-Florence Loyer, Media Relations, +33 (0)1 44 71 98 50, afloyer@newcap.fr
1 Strategic insights into the orthopaedic industry, June 2012
2 French Health Authority (HAS)
Press release http://hugin.info/159969/R/1858120/650723.pdf
HUG#1858120