CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
April 17, 2024—Roche announced that its Elecsys pTau217 assay received breakthrough device designation from the FDA. The blood test, which is being developed in collaboration with Eli Lilly, will be used to help identify the presence or absence of amyloid pathology.
The Elecsys phospho-tau (217P) is intended to be an in vitro diagnostic immunoassay for the quantitative determination of the protein pTau217 in human plasma from people aged 60 years and older. A positive Elecsys pTau217 result indicates a high likelihood of having a positive amyloid PET/cerebrospinal fluid result; a negative result indicates a high likelihood of having a negative amyloid PET/CSF result. The pTau217 result should be used in conjunction with other clinical information.