C2N Diagnostics on Thursday announced the publication of a study further confirming the sensitivity of its PrecivityAD blood test for diagnosing Alzheimer’s disease.
The study, published in the Annals of Clinical and Translational Neurology, analyzed the performance of the PrecivityAD test in a study involving 200 Australian Imaging, Biomarker & Lifestyle Flagship Study of Ageing (AIBL) participants who were either cognitively impaired or healthy controls, and for whom a blood sample and amyloid PET imaging were available. The results show that the amyloid probability score (APS) as measured by the PrecivityAD test accurately reflects the amyloid pathology characteristic of progressive Alzheimer’s disease.
In a statement, C2N added that the study provides evidence that the previously established APS cutoff values have high diagnostic performance when used across different cohorts. These APS cutoff values are one of the EU/US/Clinical Trials in Alzheimer's Disease (CTAD) Task Force’s key recommendations. Sensitivity for identifying amyloid presence by amyloid PET imaging in individuals in the intended use population was about 85%, with specificity of 96%.
Moreover, the APS model had strong diagnostic performance among healthy people. These findings support future studies evaluating the potential of the PrecivityAD test as a biomarker screening test in cognitively unimpaired individuals at high risk for developing Alzheimer’s disease, C2N said.