P2‐056: ADtect® ‐ A Novel Blood Test for the Early Detection of Alzheimer's Disease

It is generally accepted that early diagnosis and active management strategies can temporarily delay the onset of the more debilitating symptoms of Alzheimer's disease (AD). Early and accurate detection of AD is therefore critical for improving the quality of life of the patient and their caregivers. We have recently developed a blood test that can be used to aid the early diagnosis of AD. Our unique approach detects the presence of disease by measuring the pattern of specific gene expression changes in peripheral blood cells. This is a novel diagnostic approach as it measures the secondary effects of the disease and not those genes thought to be responsible for the onset of the disease itself. The test requires a 2.5 mL venous blood sample collected in an FDA approved PAXgene tube, which stabilizes and preserves the RNA expression pattern. The RNA is then extracted and cDNA prepared before application to a low density array (ADtect®). This array contains the primary reagents necessary for the real time (RT)-PCR analysis of a unique selection of 96 gene assays and is run on a commercially available RT-PCR platform. The performance of each of the 96 gene assays is subsequently evaluated by an algorithm that results in a test score value indicating the presence or absence of AD. Using this approach in three independent cohorts we have been able to discriminate AD subjects from cognitively healthy age-matched controls with 70-87% accuracy. Our current findings indicate that the AD-specific gene signature is a reliable and diagnostically relevant biomarker for the early detection of AD. Preliminary data indicate that the test can discriminate AD from other neurological diseases, such as Parkinson's Disease. Initial findings also suggest that the secondary response observed in other dementia types reflects their different biology.