The U.S. Food and Drug Administration (FDA) has granted a breakthrough device designation for Elecsys pTau217, a blood test co-developed by Roche (SWX: ROG) and Eli Lilly (NYSE: LLY), aimed at detecting amyloid pathology, a hallmark of Alzheimer’s disease. This designation is significant in the context of the growing global incidence of Alzheimer’s, with an estimated 75% of cases remaining undiagnosed. The test is intended to expand access to Alzheimer’s therapies by aiding in earlier and more accurate diagnosis.
The Elecsys pTau217 is an in vitro immunoassay designed to analyze human plasma samples from individuals aged 60 and older, quantifying the protein phospho-tau (217P), or pTau217. This phosphorylated fragment of the tau protein serves as a biomarker crucial for differentiating Alzheimer’s disease from other neurodegenerative disorders.- Flcube.com
