Two Research Studies Bolster Method That C₂N’s PrecivityAD™ Blood Test Uses to Aid Clinicians in Alzheimer’s Disease Diagnoses
Findings Presented at Alzheimer’s Association International Conference 2021
DENVER — July 29, 2021— Two recent studies demonstrated that the scientific method that serves as the basis for C2N Diagnostics’ PrecivityAD™ blood test scored best compared to others assays in their respective ability to identify amyloid plaque. The C₂N Diagnostics PrecivityAD™ blood test that clinicians use to aid in diagnosing Alzheimer’s disease is underpinned by the liquid chromatography–mass spectrometry (LC-MS/MS) assay that Dr. Randall J. Bateman and his laboratory developed at Washington University. In the studies, the liquid chromatography–mass spectrometry (LC-MS/MS) assay scored highest in its ability to identify amyloid plaque, an essential measurement for clinicians detecting Alzheimer’s disease. C₂N under a technology transfer agreement with Washington University, developed this mass spec assay into the PrecivityAD™ blood test.
BioFINDER’s large comparison of blood plasma amyloid-beta assays found that the Washington University assay performed the best out of seven assays, including in the measurement of phosphorylated tau-217, an Alzheimer’s biomarker. Shorena Janelidze, a researcher at Sweden’s Lund University, presented the results at the Alzheimer’s Association’s International Conference 2021 in her paper “Detecting amyloid positivity in early Alzheimer disease using plasma biomarkers.” She and her colleagues studied 895 participants with early disease and patients with mild cognitive impairment from two independent cohorts.
Separately, a group of leading researchers[1] presented their round-robin findings that measuring amyloid beta (Aβ) in a patient’s blood can be a pre-screen or a substitute for costly PET scans or invasive cerebrospinal fluid (also known as spinal tap) screenings that clinicians use to diagnose Alzheimer’s disease. The researchers examined the performance of six plasma Aβ assays in their ability to identify Aβ as determined by PET scans; they found that the LC-MS/MS assay that Dr. Bateman developed performed best in its ability to identify amyloid plaque.
Each of the 121 participant’s samples was tested in a blinded fashion on all six assays with analytical controls. The researchers stated that “Only one assay performed better than the reference model on Aβ 42/40 ratio alone” and “When applied to participant selection, [PET and CSF] measures are associated with high screen failure rates and contribute to the high costs and long duration of recruitment of [Alzheimer’s disease] clinical trials.”
The research project team consisted of representatives from the pharmaceutical industry, nonprofit/patient advocacy organizations and academic institutions. Its paper is titled “Comparative analytical performance of multiple plasma Aβ42 and Aβ40 assays and their relationship to amyloid positron emission tomography (PET).”
“Both these research reports show that this specific form of mass spectrometry is the most robust method for analyzing and detecting amyloid in the blood to help in Alzheimer’s disease detection. This is important data from a pre-competitive consortium collaboration that directly compared different blood biomarkers,” says Dr. Joel Braunstein, C₂N’s co-founder, president and CEO.
PrecivityAD™ Blood Test Relies on Proprietary Platform
The PrecivityAD™ test identifies whether a patient is likely to have amyloid plaques in the brain. The test relies on precise quantitation of the Amyloid Beta 42/40 ratio (Aβ 42/40) and detection of the Apolipoprotein E proteotype (equivalent to ApoE genotype) in blood samples, using C₂N’s proprietary mass spectrometry platform.
The PrecivityAD™ test is intended for use in individuals experiencing memory and thinking issues. The test is only available through an order by a physician.
The PrecivityAD™ test does not involve any radiation and is non-invasive. These features help make the test more accessible than other diagnostic methods that physicians use to evaluate issues with memory and thinking.
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About C2N Diagnostics, LLC
C₂N’s Diagnostics’ vision is to bring Clarity Through Innovation™. It focuses its therapeutic discovery efforts around mechanism-based approaches to prevent or stop the progression of human neurological disorders. Diagnostic efforts revolve around bringing accurate, widely accessible, and cost-effective blood tests to the clinic for the betterment of patient care and brain health monitoring. For more information visit www.C2N.com.
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[1] Stephen Zicha, Ph.D.; Randall J. Bateman, M.D.; Leslie M. Shaw, Ph.D.; Anthony W. Bannon, Ph.D.; Henrik Zetterberg, M.D., Ph.D.; Wesley A. Horton, M.S.; Michael Baratta, B.A., MCAHPM; Hartmuth C. Kolb, Ph.D.; Iwona Dobler, Ph.D.; Emmanouil (Manos) Spanakis, M.S.; Wenting Wang, Ph.D.; David L. Raunig, Ph.D.; Ziad S. Saad, Ph.D.; Yulia Mordashova, M.S.; Yan Li, Ph.D.; Nicole L. Bjorklund, Ph.D.; Rebecca M. Edelmayer, Ph.D.; Robert L. Martone, Ed.M.; Carrie E. Rubel, Ph.D.; Kwasi G. Mawuenyega, Ph.D.; James G. Bollinger, Ph.D.; Christopher J. Weber, Ph.D.; Emily A. Meyers, Ph.D.; William Z. Potter, M.D., Ph.D., The FNIH Biomarkers Consortium Plasm Aβ Project Team