Beckman Coulter Diagnostics has secured a CE mark for a blood test to aid in the clinical evaluation of amyloid pathology under the European Union’s in vitro diagnostic regulation (EU IVDR).
Using ALZpath’s pTau217 antibody, the Danaher subsidiary’s assay measures phosphorylated tau (pTau217), a well-established biomarker associated with Alzheimer’s, to assess the potential onset of the disease in patients exhibiting symptoms of cognitive decline. Beckman Coulter signed a licensing agreement with ALZpath for the use of its antibody in July 2024.
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Beckman highlighted that the test will advance the assessment of Alzheimer’s disease in routine clinical settings and to provide an ‘operationally scalable’ method of evaluating Alzheimer’s-related pathology within laboratory workflows.
Beckman’s CMO, Dr Chris Bird, commented: “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.
“By making testing more accessible and operationally scalable, it helps integrate biomarker-based assessment into everyday clinical practice.”
Alongside its blood test’s CE mark, Beckman is also releasing the Access BD-pTau217 research use only (RUO) assay for selectively detecting low molecular weight pTau217 in blood samples using its DxI 9000 Analyzer. With a release date yet to be revealed, the RUO assay will be showcased at the upcoming 2026 Alzheimer’s Association International Conference (AAIC), taking place in London, UK on 12-15 July.
By targeting the short form of pTau217 originating in the brain, the new research assay is designed to enhance biological specificity and provide precise characterisation of central nervous system phosphorylated Tau217 signals in blood, the company stated.
“By focusing on brain-derived pTau217, this assay is designed to deliver a higher level of biological specificity, helping researchers more precisely identify tau pathology in blood most relevant to their studies,” explained Dr Jeremiah Hinson, chief scientific officer for neurodegenerative diseases at Danaher. “This increased specificity can bolster confidence in studying Alzheimer’s disease staging and support new insights into the biological inflexion points that define how the disease evolves.”
CE mark for Beckman’s pTau217 assay follows European clearance for Roche’s Elecsys pTau217 blood test in May 2026.
The advancement of diagnostics has become especially important due to the development of next-generation Alzheimer’s therapies. Pharmacologic approaches to treating Alzheimer’s disease have gained widespread attention following the US Food and Drug Administration’s (FDA) approval of Biogen’s Leqembi (lecanemab) and Eli Lilly’s Kisunla (donanemab) in 2023 and 2024, respectively. According to GlobalData analysis, sales of Leqembi and Kisunla could generate respective global sales of $3.7bn and $2.7bn in 2032.
