Abstract Details

Title Clinical Diagnostic Laboratory Experience With Alzheimer’s Disease Blood Biomarker Testing: Insights Into Healthcare Provider Test Utilization and Patient Results

Topic Aging, Dementia, and Behavioral Neurology

Presentation(s) P7 - Poster Session 7 (5:00 PM-6:00 PM)

Poster/Presentation
Number 3-012

Objective To analyze real-world HCP utilization of a high performing Alzheimer’s disease (AD) blood biomarker (BBM) test.

Background Little data exists regarding real-world HCP adoption practices of AD BBMs. Scientifically robust BBM tests stand to provide accurate and more equitable access to detecting brain amyloid pathology, a pathognomonic of AD. A blood test with an algorithm combining BBM ratios Abeta(Aβ)42/40 and %p-tau217 has demonstrated concordance with amyloid PET scan and CSF analysis in symptomatic patients. Results are reported as a numeric score (APS2) from 0-100, with ≥48 interpreted as positive, high likelihood for brain amyloid pathology. Clinical diagnostic laboratory examination of HCP ordering, patient demographics and test results may provide information about BBM utilization.

Design/Methods Data regarding 1000 consecutive patient samples analyzed with the PrecivityAD2 blood test, C2N Diagnostics, LLC (St. Louis, MO) at start of Q2 (April 1), 2024, was retrospectively evaluated for age, self-reported sex and race/ethnicity, ICD-10 codes. Statistical analyses were performed to evaluate relationships between patient demographics and test results.

Results 84.3% of patients were >65 years old at sample collection (median 75; range 46-98). 57.6% of patients reporting sex were female. 63.5% of patients had race/ethnicity data: 82.0% were White; 5.4% Black; 1.7% Asian; 10.9% Other/Unknown race; 4.7% indicated Hispanic ethnicity. 54.9% of APS2 results were positive, 45.1% negative; 87.2% of APS2 values were <30 or >60. Age positively correlated with APS2 values; there was no statistically significant correlation between patient sex, race/ethnicity and APS2 result. 83.8% HCP offices were metropolitan. Most common testing indications were MCI (32.4%), other amnesia (14.8%), AD unspecified (14.4%) and AD late-onset (8.6%).

Conclusions All patients received positive/negative results. Similar to previous studies, ~90% had APS2 values closer to 0 or 100 that were associated with higher (>93%) NPV and PPV. No other demographic factors besides age were helpful in distinguishing likelihood of amyloid plaques.

Authors/Disclosures
Justine Coppinger, Other (C2N Diagnostics) PRESENTER	Ms. Coppinger has received personal compensation for serving as an employee of C2N Diagnostics, LLC. Ms. Coppinger has stock in C2N Diagnostics, LLC.
Sheena K. Aurora, MD (Department of Neurology and Neurological Sciences)	Dr. Aurora has received personal compensation for serving as an employee of Alzheimer's Association.
Sutapa Ray, PhD (C2N Diagnostics)	Dr. Ray has received personal compensation for serving as an employee of C2N Diagnostics.
Joel Braunstein (C2N Diagnostics, LLC)	Dr. Braunstein has received personal compensation for serving as an employee of C2N Diagnostics. Dr. Braunstein has received personal compensation in the range of $100,000-$499,999 for serving as an officer or member of the Board of Directors for C2N Diagnositcs.
Phillip Verghese (C2N Diagnositics)	No disclosure on file
Tim West, PhD	Dr. West has received personal compensation for serving as an employee of C2N Diagnostics, LLC. Dr. West has stock in C2N Diagnostics, LLC.

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