On 11 April, Roche announced that its blood test, Elecsys pTau217, has been granted breakthrough device designation from the US Food and Drug Administration (FDA) for earlier diagnosis of Alzheimer’s disease (AD). The blood test, which is being developed in collaboration with Eli Lilly, works to identify the presence or absence of amyloid pathology, a pathological feature of AD. Elecsys pTau217 is intended to be an in-vitro diagnostic immunoassay for the quantitative determination of the protein pTau217 in plasma from people aged 60 years and older. According to the press release, pTau217 is a phosphorylated fragment of the protein tau, used as a biomarker to distinguish AD from other neurodegenerative disorders. A positive Elecsys pTau217 result indicates a high likelihood of having a positive amyloid positron emission tomography (PET)/cerebrospinal fluid (CSF) result, while a negative Elecsys pTau217 result indicates a high likelihood of having a negative amyloid PET/CSF result.
The pTau217 result should be used in the diagnostic pathway in conjunction with other clinical information, the company said. If approved, the test will aid healthcare providers in identifying amyloid pathology. Both companies believe that the test could help broaden and speed access to diagnosis and appropriate care, including participation in clinical trials and access to approved disease-modifying therapies. The Breakthrough Devices Program is a voluntary program for certain medical devices that provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition. This program is designed to expedite the development and review of these medical devices.
