C2N Diagnostics has reported positive results from the clinical study that evaluated APTUS-Aβ blood test’s accuracy in detecting pathology of Alzheimer’s disease in the brain.
Alzheimer’s disease is a neurodegenerative disorder that affects nearly 5.7 million people in the US and 34 million people worldwide.
The APTUS-Aβ blood test measures amyloid beta proteins in blood samples and can be used to predict the presence of Alzheimer’s pathology in a patient’s brain.
To conduct the study, the company collected blood samples from individuals enrolled at six different locations across the US.
The study measured the performance of APTUS-Aβ blood test in 415 samples. The study found that the APTUS-Aβ blood test produced an area under the receiver operator curve (ROC-AUC) performance of 0.86.
The study report claimed that the blood test accurately predicted the presence or absence of brain amyloid, one of the potential biomarkers of Alzheimer’s disease.
Moreover, the study combined the age factor and presence of the ApoE4 gene, a genetic risk factor for developing Alzheimer’s disease and found that the overall test performance increased to an AUC of 0.90.
C2N Diagnostics CEO Joel Braunstein said: “We are extremely excited about the results from this study showing a high degree of agreement between our blood test and the established, more invasive and costly methods of detecting brain amyloidosis.
“With the diversity in how samples were handled and stored at the different sites, we believe that standardising sample collection and amyloid definition can lead to an even higher level of performance than what we found in this proof-of-concept study. We are delighted that the robustness of the APTUS-Aβ blood test allowed us to reliably measure the analytes in these samples.”
The company has already collected blood samples from participants enrolled in their PARIS (Plasma Test for Amyloid Risk Screening) study, a pivotal trial that will validate the performance of APTUS-Aβ test against the amyloid PET images of individuals.
The National Institutes of Health and BrightFocus Foundation funded the test.
In January, the company received breakthrough device designation from the US Food and Drug Administration for brain amyloidosis blood test to screen Alzheimer’s disease risk.