ExonHit has presented clinical data on the validation set ‘Alzheimer patients versus healthy controls’ for AclarusDx, its blood-based diagnostic test for the detection of Alzheimer’s disease (AD). This set of data will support the launch of a test designed to differentiate AD patients from healthy individuals and will be the first assay of the AclarusDx product line
Peter Snyder, vice president for Research for Lifespan, and a Professor of Clinical Neurosciences at the Warren Alpert Medical School of Brown University, said: “Many challenges exist today with respect to the clinical diagnosis of AD patients. AclarusDx may be an important new tool to help identify clinical populations who will potentially benefit most from novel and exciting therapeutic advances.”
The patient population for the clinical validation study covered the range of severe through mild AD, to ensure the signature performed across the continuum of the disease state where subjects presenting symptoms of AD were having a MMSE (Mini-Mental State Examination) score of less than 28. Over 200 individuals were assessed in the study. From this total, AclarusDx showed an overall accuracy of 71% identifying patients with AD correctly in 74% of all cases.
The identification and removal of ambiguous samples increased the accuracy of the test to 75%, and the number of correctly identified AD patients to 80%. The results from the clinical validation study suggest that AclarusDx, a non-invasive blood based test, can be used within the battery of cognitive instruments to help refine and classify the patient population for clinical trials.
ExonHit will first introduce AclarusDx as a Research Use Only service to pharmaceutical companies and leading academic centers conducting clinical trials in Alzheimer’s disease.