Beckman Coulter Receives CE Mark for Alzheimer’s p-Tau217 Assay
By Dr. Zubair Khalid, DVM, MS, PhD ·
Key Takeaways
- Beckman Coulter has obtained a CE mark for its Access p-Tau217 assay, enabling its clinical use in European markets that recognize this certification.
- The Access p-Tau217 assay is designed to detect phosphorylated tau protein (p-Tau217) in blood, a biomarker strongly associated with Alzheimer's disease pathology.
- This blood-based assay represents a less invasive and potentially more cost-effective diagnostic approach compared to traditional methods like cerebrospinal fluid (CSF) analysis or positron emission tomography (PET) imaging for amyloid and tau pathology.
- The availability of this assay can facilitate earlier and broader patient identification for both therapeutic interventions and participation in clinical trials for Alzheimer's disease.
- Regulatory approval and market launch details for regions outside of Europe, such as the United States, are separate considerations and were not specified in the announcement.
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