ExonHit Launches First Product in Alzheimer
“Alzheimer’s disease is a multi-factorial and a complex pathology. Currently, its diagnosis is mainly based on clinical criteria, i.e., relies on subjective measurements. Including subjects who are not properly characterized may easily increase the cost of a clinical study and potentially jeopardize its success,” commented Loïc Maurel, M.D., President of the Management Board of ExonHit Therapeutics. “The use of AclarusDx™ Alzheimer’s test could be a tremendous asset for the pharmaceutical industry as it has the potential to identify populations of patients who might benefit the most from therapeutic advances in AD.”
The launch of AclarusDx™ Alzheimer’s test as a RUO product is the first step in ExonHit’s commercial strategy in which trial sponsors will send patient blood samples for analysis in ExonHit’s GLP-compliant laboratories in the US. In parallel, the Company is preparing the launch of its product in the clinical in vitro diagnostics (IVD) market with partners. ExonHit is anticipating a CE marking in Q4 2010 for a European launch in Q1 of 2011. Regarding US marketing approval, discussions have been initiated with the FDA to define the exact regulatory path to meet IVD requirements.
Organizations
Other news from the department research and development
These products might interest you
Whatman™ folded filter papers by Cytiva
Whatman folded filter papers
Convenient folded formats speed up your sample preparation
Systec H-Series by Systec
Safe, reproducible and validatable sterilization of liquids, solids and waste
Autoclaves with 65-1580 liters usable space, flexibly expandable for various applications
Get the life science industry in your inbox
From now on, don't miss a thing: Our newsletter for biotechnology, pharma and life sciences brings you up to date every Tuesday and Thursday. The latest industry news, product highlights and innovations - compact and easy to understand in your inbox. Researched by us so you don't have to.