Beckman Coulter Receives CE Mark for Alzheimer’s p-Tau217 Assay

Diagnostics company Beckman Coulter has earned a CE mark in Europe for its Access p-Tau217 assay. The regulatory clearance adds a new test to the company’s growing portfolio of Alzheimer’s disease diagnostic tools.

The Access p-Tau217 assay measures a form of tau protein in blood that has been linked to Alzheimer’s pathology. With the CE mark, Beckman Coulter can now market the assay for clinical use in European countries that accept the certification.

The company did not announce a specific launch date or pricing details in the announcement.

Why it matters

Blood-based biomarkers such as p-Tau217 are becoming increasingly important in Alzheimer’s research and clinical practice. They offer a less invasive and potentially lower-cost alternative to cerebrospinal fluid analysis or PET imaging for detecting amyloid and tau pathology. Earlier and more accessible diagnosis could help identify patients for treatment and clinical trials, although the assay’s performance and regulatory status in other regions, including the United States, remain separate considerations.

Source: original report