C₂N Diagnostics has reported positive data from a study that showed a new blood test, which combines a unique p-tau217 ratio with an Amyloid beta (Aβ) 42/40 ratio, improves testing performance in identifying Alzheimer’s brain pathology.
The combination increases accuracy compared to more complex amyloid PET imaging and invasive cerebrospinal fluid tests.
The study was conducted on 221 difficult-to-diagnose individuals dealing with cognitive impairment of unclear aetiology who were part of the IDEAS study.
It was observed that the addition of the company’s p-tau217 ratio measurement to the existing Aβ42/40 ratio measurement enabled the identification of Alzheimer’s brain pathology patients, even at the earliest stages of the disease.
The integrated data obtained from the p-tau217 ratio and Aβ42/40 ratio combination achieved 90% accuracy and 0.96 AUC performance in identifying the presence or absence of brain amyloid plaques when compared to the quantitative results obtained using amyloid PET imaging.
C₂N Diagnostics CEO Dr Joel Braunstein said: “We are committed to transforming the way in which patients around the world receive a timely and accurate diagnosis for their memory concerns.
“Proper diagnosis is the first step in a patient’s journey to receive the care they need for their brain health.
“The progress we are making with the development of a logistically simple, cost-effective, and widely accessible blood test that determines the presence or absence of Alzheimer’s brain pathology with similar levels of performance to more invasive testing standards brings us one step closer to realising our ambitions.”
Using high-resolution mass spectrometry, the new C₂N assay precisely measures multiple different proteins implicated in Alzheimer’s-related brain changes from a single blood sample.
These markers include the beta-amyloid 42 and 40 peptides as well as different phosphorylated and nonphosphorylated tau protein forms, including forms with phosphorylation at the tau217 and tau181 sites.
In May, the company launched the p-tau Multi-Analyte Assay to advance the field of Alzheimer’s disease and brain health.