Brain health diagnostics company C2N Diagnostics has unveiled its PrecivityAD2 blood test to assess patients with symptoms and signs of Alzheimer’s disease (AD) and other causes of cognitive decline.
The PrecivityAD2 test is an analytically and clinically validated blood test that is intended to help medical professionals diagnose or rule out Alzheimer’s disease in people who have dementia or mild cognitive impairment.
According to US-based C2N Diagnostics, the test is designed as a clinical care assay to meet the standard of care with currently available PET scans and cerebrospinal fluid tests.
It concurrently quantifies specific plasma amyloid beta and tau peptide concentrations to detect the Aβ42/40 Ratio and p-tau217/np-tau217.
To determine whether a patient is positive or negative for their presence by amyloid PET scan, the ratios are combined into a proprietary statistical algorithm to calculate the Amyloid Probability Score 2 (APS2).
The brain health diagnostics company said that the blood test has an overall test performance statistic of 0.94 AUC and 88% accuracy in a clinical validation trial.
It is also backed by results from the BioFINDER-Primary Care and Memory Care studies at Lund University in Sweden.
In the study of 1,000 patients, the PrecivityAD2 test showed very high accuracy in the detection of Alzheimer’s disease pathology, mainly using CSF biomarkers as the reference standard.
C2N president and CEO Joel Braunstein said: “We believe the PrecivityAD2 test represents the next generation in blood biomarker tests and will help establish a new standard in Alzheimer’s disease diagnosis.
“The 2022 Clinical Trials on Alzheimer’s Disease Task Force report outlined that combined biomarkers can be especially helpful in avoiding misdiagnosis, and PrecivityAD2 does just that by harnessing two established biomarkers in one assay.”
The latest product joins the firm’s Precivity-ApoE blood test, which is indicated for adult patients for whom knowledge of apolipoprotein E2, E3, E4 allele status can help in medical management and treatment decisions.
C2N introduced the PrecivityAD blood test nearly three years ago.
According to the brain health diagnostics company, the full test portfolio enables healthcare professionals to make an earlier and more precise diagnosis of the pathology associated with Alzheimer’s disease.
