ExonHit Gets EC Clearance for Alzheimer Disease In Vitro Diagnostic
Blood test will undergo further evaluation through its use at Memory Centers in France.!--h2>
ExonHit Therapeutics received CE marking for AclarusDx™, its blood-based test intended to help in the diagnosis of Alzheimer disease (AD). Starting in April the firm will make the diagnostic available at Memory Centers.
The test is based on the compared analyses of AD patients’ transcriptomes with that of healthy subjects. It was developed by identifying a biomarker signature comprising more than 130 genes including some particularly involved in inflammatory and immune mechanisms observed in AD. A French multicenter blind validation study involving 164 individuals helped to establish the assay performance. Sensitivity was established at 81% and specificity at 67%.
AclarusDx was launched for research use only in December 2009. This year ExonHit plans to collaborate with key opinion leaders to set up a study in a real clinical setting that will 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,” notes Loïc Maurel, M.D., president of the management board of ExonHit Therapeutics. “This collaboration with the French AD experts is essential to understand the role that AclarusDx could play in the early diagnosis of the disease.”
AclarusDx has been utilized since the end of 2009 in clinical research, according to ExonHit. It is part of the MAPT (multidomain alzheimer preventive trial) study, in which the main objectives are to assess over three years the comparative efficacy of a pharmacological intervention (omega-3 fatty acid supplement) and a multidomain intervention (nutrition, physical exercise, cognitive stimulation, and social activities). It will also evaluate their association on the evolution of cognitive functions in individuals aged 70 and above.
ExonHit is associated with Toulouse University Hospital, the trial sponsor, and The Institut de Recherche Pierre Fabre to evaluate the ability of AclarusDx and potentially other transcriptomic signatures in the early identification of aged subjects progressing to Alzheimer disease.