Clinical and Analytical Performance of DuritectTM: A Novel Blood-Based Autoantibody Diagnostic Sceening Platform for Alzheimer’s and Parkinson’s Diseases
Cassandra DeMarshall1, Jeffrey Viviano1, Anuradha Krishnan1, Dennis Hutchison1, Mert Sahin1, Robert Nagele2
1Durin Life Sciences, 2Geriatrics, New Jersey Institute for Successful Aging at Rowan University
Objective:
In the present study we demonstrate the clinical and analytical utility of the DuritectTM platform, a diagnostic screening solution comprised of panels of customized blood-based autoantibody biomarkers capable of detecting disease-related processes resulting from ongoing Alzheimer’s or Parkinson’s disease pathology, using a proprietary risk score capable of predicting an individual’s likelihood of developing AD or PD in the future.
Background:
There is an urgent need to identify blood-based biomarkers that can accurately diagnose AD and PD in the earliest stages of disease pathology.
Design/Methods:
Utilizing DuritectTM’s autoantibody biomarker panels and Luminex xMAP® technology, blinded sera samples from ADNI subjects with confirmed presymptomatic, prodromal (MCI), and mild-moderate AD, as well as early-stage PD subjects (Hoehn and Yahr stages 1-2.5) from various sources, together with healthy age- and-sex-matched control subjects were screened to detect the presence of AD or PD-related pathology. Autoantibody levels were evaluated using a proprietary machine learning algorithm to calculate an individual Disease Risk Score (DRS) for each patient sample, indicating whether that individual has a typical, or increased risk of ongoing AD or PD pathology.
Results:
Results demonstrate that DuritectTM’s disease-specific panels of autoantibody biomarkers corresponding to a patient’s AD or PD risk score successfully differentiated both AD and PD subjects from age- and sex-matched controls, demonstrating greater than 90% overall accuracy, sensitivity, and specificity in both diseases.
Conclusions:
DuritectTM is the first blood-based autoantibody diagnostic platform for the detection of neurodegenerative diseases. CLIA validated tests against AD or PD-related pathology in patients presenting in primary care settings with signs or symptoms for suspected Alzheimer’s or Parkinson’s disease are already on the market. DuritectTM is an accurate, minimally invasive, and inexpensive diagnostic screener, for the detection of early, AD-related pathology associated with prodromal (MCI) and later stages of AD, as well as early-stage PD-related pathology.
Disclaimer: Abstracts were not reviewed by Neurology® and do not reflect the views of Neurology® editors or staff.