Diagnostics specialist Beckman Coulter has expanded its portfolio of Alzheimer’s disease diagnostics by earning a CE mark in Europe for its Access p-Tau217 assay.
The blood test was designed to support clinical evaluation of amyloid pathology in patients with signs and symptoms of cognitive decline, the company said in a July 7 press release.
The approval falls under the EU’s IVDR (In Vitro Diagnostic Regulation) that governs diagnostic medical tests used outside the human body.
The company also unveiled its high-specificity Access BD-pTau217 assay for research only during the Alzheimer's Association International Conference in London, England.
It can detect the short-form (low-molecular weight) pTau217 in blood samples using the DxI 9000 Analyzer. By targeting the short form of pTau217 originating in the brain, the assay enhances biological specificity for a more precise characterization of central nervous system phosphorylated Tau217 in blood.
Both assays use the DxI 9000 Immunoassay Analyzer that allows labs to better manage clinical and research tests on a single high-precision analyzer.
“Our CE-marked Access p-Tau217 assay brings a well-established Alzheimer's biomarker into routine clinical workflows, enabling laboratories to scale blood-based evaluation of disease pathology more efficiently,” Chris Bird, Beckman’s chief medical officer, said in a statement. “By making testing more accessible and operationally scalable, it helps integrate biomarker-based assessment into everyday clinical practice.”
The Access p‑Tau217 assay was developed using AlzPath's antibody, which has been cited in more than 200 peer‑reviewed publications.
The company expects the demand for Alzheimer's disease diagnostics will continue to grow with blood‑based testing taking an important role for consistent evaluation across clinical settings.
The CE mark comes just shy of two weeks since Abbott announced it was teaming up with Alzheimer’s disease blood test developer ALZpath as part of a deal to incorporate ALZpath’s phosphorylated tau 217, or pTau217, antibody into the development of an in vitro diagnostic test.
The test would be used with Abbott’s Alinity ci-series systems.