Biotech company Exonhit has received an Institutional Review Board (IRB) approval to start a 160-patient pilot clinical trial to evaluate the clinical utility of AclarusDx, a blood-based test as a diagnostic tool for Alzheimer's Disease (AD).
The new blood test is based on the compared analysis of AD patients' transcriptome with that of healthy controls.
The US-based pilot study will begin enrolling patients in November 2011 and the blood samples will be sent to Exonhit's Paris facility for AclarusDx test analysis.
Exonhit Management Board president Loïc Maurel said the aim of the study is to provide 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 multicentre blind validation study in France has showed that the test demonstrated a sensitivity of 81% and a specificity of 67%.