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.

Beckman highlighted that the test will advance the assessment of Alzheimer’s disease in routine clinical settings and provide an ‘operationally scalable’ method of evaluating Alzheimer’s-related pathology within laboratory workflows.