An institutional review board has approved a pilot clinical trial aimed at evaluating the performance of ExonHit Therapeutics' test for Alzheimer's disease, AclarusDx.
The Paris-based firm said last week that the study, the first AclarusDx trial to be conducted in the US, will be carried out by the Cleveland Clinic and that patient recruitment will begin next month.
ExonHit received a CE-IVD Mark for AclarusDx in March. The Affymetrix-manufactured test is currently offered to select European customers through a partnership with Craigavon, UK-based Almac Diagnostics (BAN 7/5/2011).
ExonHit said it hopes to recruit 160 patients for the trial from three Cleveland Clinic sites: the Lou Ruvo Center for Brain Health in Las Vegas, from which the trial will be coordinated; the main campus in Cleveland; and Lakewood Hospital in Lakewood, Ohio.
Loïc Maurel, president of the management board of Exonhit, said in a statement that the firm's "ultimate goal is to define the clinical utility of AclarusDx to provide primary care physicians with a diagnostic tool that will help them identify patients at high risk of having AD and to prescribe a complete diagnostic workup."
The company has said previously that it hopes to achieve US Food and Drug Administration clearance for the test in 2012.