Clarksburg MD – A BrightFocus Foundation-funded project to develop a blood-based screening test for Alzheimer’s disease has passed proof of concept stage and C2N Diagnostics, the company spearheading the development of the test, will move forward to seek approval for use in research and clinical settings, according to a presentation at a major scientific conference.
If approved for use, the APTUS™-Aβ blood test would allow screening, through a simple blood draw, for whether a person has the presence of Alzheimer’s pathology in the brain. This could pave the way for greater enrollment in clinical trials and the evaluation of new treatments for earlier and better patient care.
“This is tremendously encouraging news. BrightFocus has supported this innovative project from its beginning,” said the foundation’s President and CEO Stacy Pagos Haller. “In the face of such a devastating disease, it is a powerful reminder that research equals hope.”
BrightFocus has funded the foundational concepts behind this work through early grants to Washington University in St. Louis’ David Holtzman, MD, and Randall Bateman, MD, scientific co-founders of C2N.
“We are so pleased that BrightFocus committed to us so early as a partner during our development of the APTUS™-Aβ test. With their support, we have been able to develop a blood test that has considerable promise to detect early Alzheimer’s pathology among individuals with elevated risk,” said Joel Braunstein, MD, MBA, the Co-Founder, President, and CEO of C2N Diagnostics LLC, which in 2016 received a grant for this work from BrightFocus’ Alzheimer’s Disease Research program.
From a study launched earlier this year, C2N showed that the APTUS™-Aβ blood test strongly and reliably predicted the presence or absence of disease associated brain beta-amyloid, early markers of Alzheimer’s disease. The APTUS™-Aβ blood test was applied to 415 samples collected from a diverse population of individuals at six different U.S. locations. Results were verified using PET scans done on the same individuals.
Despite differences in how each of the sites collected and stored the blood samples, as well as how each site defined presence of amyloid in the brain, the APTUS™-Aβ blood test performed robustly in the study. When the blood test was used in samples from patients with additional Alzheimer’s factors – age and presence of the ApoE4 gene, the strongest known genetic risk factor for developing Alzheimer’s disease results improved, according to C2N.
Earlier this year, the APTUS™-Aβ blood test received “Breakthrough Device” designation from the U.S. Food and Drug Administration (FDA) through a program designed to accelerate the path to approval. Ahead, C2N plans to seek approval for the test as an in vitro diagnostic tool to be used primarily in research settings as an efficient way to identify more people who are eligible to participate in clinical trials testing new Alzheimer’s drugs.
BrightFocus Foundation is a premier source of private research funding to defeat diseases of mind and sight – Alzheimer’s, macular degeneration and glaucoma. The nonprofit organization manages a global portfolio of nearly 200 research projects, a $43 million investment to find cures for these diseases.
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