US-based speciality diagnostics company C₂N Diagnostics has launched a high-resolution mass spectrometry-based plasma tau multi-analyte assay (p-tau MAA) for research use only (RUO).
The test uses a small sample of blood to measure different phosphorylated and nonphosphorylated versions of the tau protein, including those with phosphorylation at the tau217 and tau181 sites.
According to the firm, the assay will allow researchers to continue their research into the diagnosis of Alzheimer’s disease, monitor investigational therapy responses, and understand the disease’s underlying molecular mechanisms.
The RUO breakthrough will expand the portfolio of biomarkers that helps in disease detection and brain health assessments, said C₂N Diagnostics.
Under C₂N’s p-tau MAA RUO, researchers can analyse and characterise the assay’s capacity to identify Alzheimer’s pathology at the early stages of the disease.
The firm said that p-tau MAA delivers more power when utilised with C₂N’s plasma amyloid beta 42/40 ratio assay as it has already obtained high diagnostic performance marks.
C₂N Diagnostics chief executive officer and co-founder Dr Joel Braunstein said: “This development builds on our team’s history of providing exceptional laboratory services and products in the field of brain health.
“Our team has worked tirelessly to achieve this p-tau advancement that adds to our existing efforts to bring accurate, widely accessible and cost-effective blood tests to the clinic for the betterment of patient care.
“We look forward to sharing important data about the performance of our p-tau MAA test at upcoming medical meetings and in peer-reviewed publications.”
C₂N Diagnostics also offers PrecivityAD blood tests as an aid to Alzheimer’s disease diagnosis.
The company has earned ISO 13485:2016 Certification for its quality management system, College of American Pathologists (CAP) accreditation and Clinical Laboratory Improvement Amendments (CLIA) certification.
In December 2019, the firm reported positive results from a study of its APTUS-Aβ blood test for the identification of the existence of Alzheimer’s pathology in the brain.
