ExonHit Launches First Product in Alzheimer

07-Dec-2009 - France
ExonHit Therapeutics announced that AclarusDx™ Alzheimer’s test (formerly known as EHT Dx21), its blood-based test for the detection of Alzheimer’s disease (AD), is now available as a Research Use Only (RUO) product for pharmaceutical companies and academic centers conducting clinical trials in Alzheimer’s disease. “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.

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Topic world Diagnostics

Diagnostics is at the heart of modern medicine and forms a crucial interface between research and patient care in the biotech and pharmaceutical industries. It not only enables early detection and monitoring of disease, but also plays a central role in individualized medicine by enabling targeted therapies based on an individual's genetic and molecular signature.

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Topic world Diagnostics

Diagnostics is at the heart of modern medicine and forms a crucial interface between research and patient care in the biotech and pharmaceutical industries. It not only enables early detection and monitoring of disease, but also plays a central role in individualized medicine by enabling targeted therapies based on an individual's genetic and molecular signature.

1 whitepaper