ExonHit receives CE mark approval for AclarusDx to diagnose AD

Mar 15 2011

ExonHit Therapeutics (Paris:ALEHT) announces today CE marking of AclarusDx^™, its blood-based test intended to help in the diagnosis of Alzheimer's disease (AD). This gives AclarusDx^™ the status of In Vitro Diagnostic (IVD). It is an essential step in the product life cycle.

This CE marking will enable ExonHit, from April 2011 on, to put AclarusDx^™ at the disposal of Memory Centers, especially expert Memory Centers. ExonHit will set up, in 2011, in close collaboration with the major Alzheimer's key opinion leaders, a study in real clinical setting in order to collect "real life" data allowing to further position AclarusDx^™ within the diagnostic algorithm currently used by Memory Centers to diagnose AD.

"We are proud to be able to offer AclarusDx^™ to Memory Centers in France and to allow neurologists and geriatricians of these centers to test AclarusDx^™ in patients undergoing clinical diagnosis. This collaboration with the French AD experts is essential to understand the role that AclarusDx^™ could play in the early diagnosis of the disease," said Loïc Maurel, M.D., President of the Management Board of ExonHit Therapeutics.

AclarusDx^™ is being utilized since the end of 2009 in clinical research. It is part of the MAPT (Multidomain Alzheimer Preventive Trial) study whose main objectives are to assess, over 3 years, the comparative efficacy of a pharmacological intervention (omega-3 fatty acid supplement), a "multidomain" intervention (nutrition, physical exercise, cognitive stimulation, and social activities), or their association on the evolution of the cognitive functions in frail individuals aged 70 or more. ExonHit is associated with Toulouse University Hospital, the trial sponsor, and The Institut de Recherche Pierre Fabre in order to evaluate the interest of AclarusDx^™, and potentially other transcriptomic signatures, in the early identification of aged frail subjects progressing to Alzheimer's disease.

Source: AclarusDx